Q1 2024 Allogene Therapeutics Inc Earnings Call

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Operator: Hello, and welcome to the Allogene Therapeutics first quarter 2024 conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star, 1-1 on your telephone. You will then hear an automated message advising that your hand is raised.

Speaker Change: Hello, and welcome to the allergy Therapeutics first quarter 'twenty 'twenty four conference call.

At this time all participants are in a listen only mode.

Speaker Change: The speaker's presentation, there will be a question and answer session.

Ask the question during the session you will need to press star one on your telephone you went into your automated message advising your hand is right.

Operator: To withdraw your question, please press star 11 again. Please be aware that today's conference is being recorded. We ask that you limit yourself to one question only. I would now like to turn the conference over to Christine Cassiano, Chief Corporate Affairs and Brand Strategy Officer. You may begin.

Speaker Change: Withdraw your question. Please press star one again.

Speaker Change: Please be aware that today's conference is being recorded.

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Speaker Change: I would now like to turn the conference over to Kristy Casiano, Chief Corporate Affairs and brand strategy Officer, you may begin.

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 first quarter of 2024.

Christine Cassiano: Thank you operator, and welcome to all who have joined this call. After the market closed today, Alan allergy and issued a press release that provides a business update and financial results for the first quarter of 2024. This press release and today's webcast are both available on our website.

Christine Cassiano: This press release and today's webcast are both available on our website. Following our prepared remarks, we will host a Q&A session. We ask you to limit your questions to one per person, as we will keep this call to an hour and do our best to get to as many questions as possible. Joining me today are Dr. David Chang, President and Chief Executive Officer, Dr. Zachary Roberts, Executive Vice President of Research and Development and Chief Medical Officer, and Geoff Parker, Chief Financial Officer.

Christine Cassiano: Following our prepared remarks, we will host a Q&A session. We ask you to limit your questions to one per person as we will keep this call to an hour and do our best to get to as many questions as possible.

Speaker Change: Joining me today are Dr. David Chang, President and Chief Executive Officer, Dr. Zachary Roberts Executive Vice President of research and development and Chief Medical Officer, and Geoff Parker Chief Financial Officer. During today's call, we will be making certain forward looking statements. These may include statements regarding the success and timing of our ongoing and planned clinical trials data presence.

Christine Cassiano: During today's call, we will be making certain forward-looking statements. These may include statements regarding the success and timing of our ongoing and planned clinical trials, data presentations, regulatory filings, future research and development efforts, manufacturing capabilities, the safety and efficacy of our product candidates, expanded semicell development, and 2024 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 press release and latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward-looking statements, and AllerGene disclaims any obligation to update these statements. I'll now turn the call over to David.

Speaker Change: Patients regulatory filings future research and development efforts manufacturing capabilities, the safety and efficacy of our product candidates extended summer fill development in 2024 financial guidance among other things.

Speaker Change: These forward looking statements are based on current information assumptions and expectations that are subject to change.

Speaker Change: Scripts in a potential risks can be found in our press release and latest SEC disclosure documents.

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

David D. Chang: Thank you, Christine, and welcome to those on the call today. We are excited to speak with you today to discuss how we have continued to strengthen our allogeneic CAR-T leadership position on every front. In January, we announced our Pivot to Focus development on differentiated and competitive programs that are, importantly, designed to address unmet needs. In doing so, our future market opportunity dramatically increased. In large B-cell lymphoma alone, moving from the later line into the frontline consolidation meant that the U.S. market opportunity grew from approximately $500 million to more than $6 billion. That change meant something significant. It was time to extend our territorial rights to include all of the European Union and the U.K. from Serbia.

David D. Chang: Thank you Christine and welcome to those on the call today.

David D. Chang: We're excited to speak with you today to discuss how we have continued to strengthen our allogeneic car T. A leadership position on every front in January we announced our pivot to focus development on differentiated and competitive programs that are importantly, designed to address unmet needs in doing so.

David D. Chang: Our future market opportunity dramatically increased.

David D. Chang: In large b cell lymphoma, along moving from the later line into the frontline consolidation meant that the U S market opportunity group from approximately $500 million to more than $6 billion.

David D. Chang: That change meant something significant it was time to extend our territory rights to include all of the European Union and the UK, France, Serbia.

David D. Chang: We are excited to have executed that vision, and Geoff will provide more details on that agreement during this call. Our team is making great progress on four core programs we outlined in January. We are very proud of the transformative potential of our Pivotal Alpha 3 trial with Semicell, which is expected to read out in 2026, leading to potential BLA submission in 2027. This trial is designed to embed Semicell as a part of CureTip's first-line regimen and has the potential to change the standard of care for patients with large B-cell lymphoma.

David D. Chang: We are excited to have executed that vision and Jeff will provide more details on that agreement on this call.

David D. Chang: The last point is something I want to emphasize as that is very rare in oncology. Our SAMHSA program could also set a new standard for what a CAR T can achieve in relapse, refractory chronic lymphocytic leukemia, or CLL. Differentiation is critical across our core programs.

David D. Chang: Our team is making great progress in poor core programs, we outlined in January.

David D. Chang: Very proud of the transformative potential of our people our alpha III trial with <unk>, which is expected to read out in 2026.

David D. Chang: Leading to a potential BLA submission in 2027.

David D. Chang: This trial is designed to embed <unk> cel as a part of curative first line regimen and has the potential to change the standard of care for patients with large b cell lymphoma.

David D. Chang: The last point being something I want to emphasize as that is very rare in oncology.

David D. Chang: Ah <unk> program could also set a new standard for what a car T can achieve in relapsed refractory chronic lymphocytic leukemia or CML.

David D. Chang: Differentiation is critical across our core programs.

David D. Chang: We declared a move into the autoimmune space with the goal of resetting the immune system with a single infusion. Allo329, our next generation CD19-CD70 dual-carrier, which incorporates our Dagger technology and CRISPR-based gene editing for site-specific integration, is designed to meet the unique needs of patients with autoimmune disease. Our DAGGER technology provides a potential path to reducing or eliminating lymphoid depletion, which we believe may create more development and commercial opportunities for LO329 in autoimmune indications. Additionally, our L0316 program could be the first to demonstrate the unique potential of a CAR-T enthalotumor.

David D. Chang: We declared a move into autoimmune space with the goal of resetting the immune system with a single infusion.

David D. Chang: Our two eight to nine our next generation CD 19, CD 70 fuel car, which incorporates our <unk> technology and CRISPR based gene editing for site specific integration is designed to meet the unique needs of patients with autoimmune disease.

David D. Chang: Our data technology provide a potential path to reducing or eliminating lymphoid depletion, which we believe may create more developmental and commercial opportunities for our tweet Tonight in autoimmune indications.

David D. Chang: Our our 316 program could be the first to demonstrate the unique potential of a car T in solid tumor.

David D. Chang: We believe our $15 million California Institute for Regenerative Medicine grant awarded last month validates the remarkable inroads made in our TAVERS trial and the therapeutic potential IL-316 has for patients with advanced renal cell carcinoma. This grant funds the completion of the Phase I trial. We are grateful for the recognition from the CIRM reviewers of the potential for Allo316 to make a difference for patients.

David D. Chang: We believe our <unk> $10 million, California Institute for Regenerative Medicine Grant awarded last month payout validates the remarkable inroads made in our <unk> trial and the therapeutic potential of our 306 has for patients with advanced renal cell carcinoma.

David D. Chang: This grant funds the completion of the phase one trial, we are grateful for the recognition from the Sam reviewers of the potential for our <unk> III <unk> six to make a difference for patients.

David D. Chang: Lastly, we are pleased to have strengthened our cash runway to extend into Q3 2026. I am very excited by the caliber of investors who participated in this financing and their demonstrated commitment to our mission. In addition, members of our board and executive management, including our executive chair, Ari Veldegren, Geoff, our CFO, and I have further demonstrated our commitment to Allogene by participating in this offering. Understandably, many investors are focused on milestones related to our Pivotal Alpha 3 trial.

David D. Chang: Lastly, we are pleased to have strengthened our cash runway to extend into third quarter 2026.

David D. Chang: I am very excited by the caliber of investors, who participated in this financing and theyre demonstrated commitment to our mission.

David D. Chang: In addition members of our board and executive management, including our executive chair or a builder grant, Jeff our CFO and now I have further demonstrated our commitment to allergen by participating in this offering.

David D. Chang: Understandably many investors are focused on milestones related to our pivotal offer III trial.

David D. Chang: But it is essential to appreciate the multitude of inflection points across all our programs. Later in the call, Zach will review the development milestones across all four core programs. We will continue to focus all our resources on advancing these core programs and believe we are well positioned to change the CAR Treatment landscape to benefit patients. I'd like to turn the call over to Geoff to discuss our announcements today.

David D. Chang: It is essential to appreciate the multitude of inflection points across all our programs.

David D. Chang: Later in the call Zach will review that development milestones across all four core programs.

We will continue to focus all our resources on advancing these core programs and believe we are well positioned to change their car T treatment landscape to benefit patients.

David D. Chang: I would like to turn the call over to Jeff to review our announcements today.

Geoffrey M. Parker: Thank you, David. Let me first start with the press release we just issued announcing our $110 million equity financing. We know that our cash runway is critical. When we announced our pivot earlier this year, we had strong renewed interest from top-tier institutional investors and mutual funds. Based on those conversations, we made the strategic decision to pursue financing that builds our cash reserves and extends our runway into the second half of 2026, during which time we expect to have the interim efficacy analysis and to complete enrollment in the Alpha 3 trial.

Yes.

Jeff: Thank you David Let me first start with the press release, we just issued announcing our $110 million equity financing, we know that our cash runway is critical when we announced our pivot earlier. This year, we had strong renewed interest from top tier institutional investors and mutual funds.

Jeff: On those conversations we made the strategic decision to pursue a financing that builds our cash reserves and extends our runway into the second half of 2026 during which time, we expect to have the interim efficacy analysis and to complete enrollment of the Alpha <unk> III trial in.

Geoffrey M. Parker: In addition, this financing significantly reshapes our investor base. The quality of the investors who are part of this raise, including five of the largest institutional investors in mutual funds, leading healthcare specialists, and select members of our board of directors and management team, is indicative of the depth of interest in our Allogeneic CAR-T strategy, and we look forward to validating their belief in Allogene as we execute on our goals. Another example that underscores our belief in our programs is our just-completed amendment to our agreement with Servier. You may recall that when Allogene was formed, we had only the U.S. rights to Semicel under the Servier Agreement.

Jeff: In addition, this financing importantly, reshaped our investor base the quality of the investors who are part of this race, including five of the largest institutional investors in mutual funds, leading health care specialists and select members of our board of directors and management team is indicative of the depth of interest in our Allen.

Jeff: <unk> car T strategy, and we look forward to validating their belief in allergy as we execute on our goals.

Jeff: Another example that underscores our belief in our programs is our just completed amendment to our agreement with Servier.

Jeff: You may recall that when Allergan was formed we had only the U S rights for <unk> under the Servier agreement.

Geoffrey M. Parker: The timing for us to obtain these rights now versus a few years ago when they first became available was driven by two important factors. First, the dramatically increased market opportunity now with LBCL Frontline Consolidation and CLL. And two, the ability to establish future strategic partnerships. Let me start with the market opportunity. Our lead trial for Semicell before our announcement in January was in third-line LBCL.

Jeff: The timing for us to obtain these rights now versus a few years ago. When they first became available was driven by two important factors first the dramatically increased market opportunity now with <unk> frontline consolidation and COO and two the ability to.

Jeff: <unk> future strategic partnerships.

Let me start with the market opportunity.

Jeff: Our lead trial for stem cell before our announcement in January was in third line <unk>.

Geoffrey M. Parker: At that time, we estimated a market opportunity of approximately $500 million in that indication. After our announced pivot for this program into first-line consolidation in LBCL and relapsed refractory CLL, our new market opportunity dramatically increased to more than $6 billion in the United States. What we've just negotiated with Servier significantly expands our rights by adding the EU member states and the UK to further increase our market opportunity to more than $9.5 billion, in turn increasing the potential future revenue opportunity for Semicel by more than 50 percent.

Jeff: At that time, we estimated a market opportunity of approximately $500 million in that indication.

Jeff: After our announced pivot for this program in the first line consolidation and there'll be CL and relapsed refractory CLO, our new market opportunity dramatically increased to more than $6 billion in the United States.

Jeff: What we've just negotiated with servier significantly expands our rates by adding the EU member states and the UK to further increase our market opportunity to more than $9 5 billion in.

Jeff: In turn increasing the potential future revenue opportunity for <unk> cel by more than 50%.

Geoffrey M. Parker: We now also have the option to add Japan and China at no additional cost when we can demonstrate the resources required to advance SEMICEL in that region. This brings me to point number two, future strategic partnerships. Given the market opportunity and excitement for Semicell in community cancer centers, you might surmise growing interest in a potential partnership. And this excitement will only grow over the next 6 to 12 months as the program is de-risked. We control the only clinically validated allogeneic CD19 CAR-T product positioned to transform how and where CAR-Ts are used in heme malignancies.

We now also have the option to add Japan, and China at no additional cost when we can demonstrate the resources required to advance MSL in that region.

Jeff: This brings me to point number two future strategic partnerships.

Jeff: Given the market opportunity and excitement for stem cell and community cancer centers, you might surmise growing interest in a potential partnership and this excitement will only grow over the next six to 12 months as the program is de risked.

Jeff: We control the only clinically validated allogeneic CD 19 car T product positioned to transform how and where car Ts are used in heme malignancies.

Geoffrey M. Parker: With this agreement, we have consolidated rights in key commercial markets, making a potential partnership far more attractive. Importantly, we did so at a cost that is minimal compared to the market opportunity for Semicel. The financial terms are quite favorable for Allogene given the expanded geography. We've agreed to increase our overall regulatory milestones by $25 million, and our obligation on commercial milestones is increased by $10 million. Our royalty burden increases modestly but remains effectively the same in the low 10s to mid-teens in the U.S., and we have a flat 10% royalty in EU territories and the U.K. Our royalty would also be 10% if we pursue our rights in Japan and China.

Jeff: With this agreement we have consolidated rights in key commercial markets, making a potential partnership far more attractive.

Jeff: Accordingly, we did so at a cost that is minimal compared to the market opportunity for <unk>.

Jeff: The financial terms are quite favorable for allergan, given the expanded geography.

Jeff: We've agreed to increase our overall regulatory milestones by $25 million and our obligation on commercial milestones increases by $10 million.

Jeff: Our royalty burden increases modestly but remains effectively the same in the low tens to mid teens in the U S and we have a flat 10% royalty in the EU territory and the U K.

Jeff: Our royalty would also be 10%, if we pursue our rights in Japan and China.

Geoffrey M. Parker: Let me now turn to our financial update for the first quarter and the impact of our just-announced finances. Our cash balance as of the end of Q1 2024 was $397.3 million in cash, cash equivalents, and investments. Pro forma for the financing we announced today, our cash balance will increase to approximately $500 million. Our cash runway now extends into the second half of 2026. Q1 2024 research and development expenses were $52.3 million, which included $3.8 million in expenses associated with non-cash stock-based compensation.

Speaker Change: Let me now turn to our financial update for the first quarter and the impact of our just announced financing.

Speaker Change: Our cash balance as of the end of Q1, 2024 was $397 3 million in cash cash equivalents and investments.

Speaker Change: Pro forma for the financing, we announced today, our cash balance will increase to approximately $500 million.

Speaker Change: Our cash runway now extends into the second half of 2026.

Speaker Change: Q1, 2020 for research and development expenses were $52 $3 million, which includes $3 8 million and expenses associated with noncash stock based compensation.

Geoffrey M. Parker: General and administrative expenses in Q1 were $17.3 million, which included $8.1 million of non-cash, stock-based compensation expenses. For Q1 2024, our net loss was $65 million, or $0.38 per share, including non-cash stock-based compensation of $11.9 million in total. For 2024, we now expect a cash burn of approximately $200 million, a slight increase of $10 million to our prior guidance due to the timing impact of our revised milestone obligations to CERVI-A, offset by expected proceeds from our $15 million CIRM grant related to our ALO 316 program.

Speaker Change: General and administrative expenses in Q1 were $17 3 million, which includes $8 1 million of noncash stock based compensation expense.

Speaker Change: For Q1 2024.

Speaker Change: Our net loss was $65 million or <unk> 38 per share, including noncash stock based compensation expense.

Speaker Change: $11 9 million in total.

Speaker Change: For 2024, we now expect a cash burn of approximately $200 million.

Speaker Change: A slight increase of $10 million to.

Speaker Change: To our prior guidance due to the timing impact of our revised milestone obligations to <unk> offset.

Speaker Change: Offset by expected proceeds from our $15 million CERN grant related to our Allo 316 program.

Geoffrey M. Parker: We expect full-year 2024 GAAP operating expenses to be approximately $300 million, which includes estimated non-cash stock-based compensation expense of approximately $60 million. This guidance excludes any impact from potential business development activities. I'll now turn the call over to Zach, who will focus his comments on key milestones in our core development program.

Speaker Change: We expect full year 2024, GAAP operating expenses to be approximately $300 million, which.

Speaker Change: <unk> estimated noncash stock based compensation expense of approximately $60 million.

This guidance excludes any impact from potential business development activities.

Speaker Change: I'll now turn the call over to Zack who will focus his comments on key milestones in our core development programs.

Zachary J. Roberts: Thank you, Geoff. As I review key development milestones, I'd like to turn your attention to the new corporate presentation posted in the Investor Relations section of our website. Approximately one-third of LBCL patients who initially respond to RCHOP will likely relapse. Unfortunately, until recently, there was no way to know which patients would be cured by frontline RCHOP versus those who would experience a disease recurrence and require treatment in second line or beyond.

Zack: Thank you Jeff is that reviews key development milestones I'd like to turn your attention to the new corporate presentation posted in the Investor Relations section of our website.

Zack: Approximately one third of <unk> patients, who initially respond to R. Chop will likely relapse. Unfortunately until recently there has been no way to know which patients would be cured by frontline R. Chop versus those who had experience of disease recurrence and require second required treatment in second line or beyond.

Zachary J. Roberts: Because of this inability to give an accurate prognosis after the conclusion of front-line treatment, the standard of care after front-line treatment has, for decades, been to watch and wait for the disease to relapse. In January, we announced a partnership with Foresight Diagnostics, which is developing a novel and potentially practice-changing test for minimal residual disease, or MRD. This investigational test, when administered following completion of frontline treatment for LBCL, has the potential to offer a highly accurate prediction of future disease relapse.

Zack: Because of this inability to give an accurate prognosis. After the conclusion of frontline treatment to standard of care. After frontline treatment has for decades been to watch and wait for the disease to relapse.

Zack: In January we announced a partnership with fore sight diagnostics, who is developing a novel and potentially practice changing test for minimal residual disease or <unk>.

Zack: This investigational test when administered following completion of frontline treatment for <unk> has the potential to offer a highly accurate prediction of future disease relapses.

Zachary J. Roberts: We believe this test could provide us with the ability to identify those patients who are most likely to relapse after frontline therapy and to take action to potentially prevent that relapse, namely a consolidation dose of Semicel delivered immediately following the discovery of persistent MRD. Alpha-3 is designed with the specific attributes of Semicell in mind.

Zack: We believe this test could provide us with the ability to identify those patients who are most likely to relapse after frontline and to take action to potentially prevent that relapse, namely a consolidation dose of <unk> delivered immediately following the discovery of persistent MRV.

Zack: Alpha <unk> is designed with the specific attributes of <unk> in mind first and foremost it maximizes the allogeneic advantages of <unk> is a onetime off the shelf treatment that can be administered immediately upon discovery of MRV. Following six cycles of R. Chop.

Zachary J. Roberts: First and foremost, it maximizes the allogeneic advantages of Semicell as a one-time, off-the-shelf treatment that can be administered immediately upon discovery of MRD following six cycles of R-CHOP. If Alpha 3 is successful, SEMICEL could become the standard 7th cycle of frontline treatment available to all eligible patients with MRD. Additionally, Alpha 3 builds on the growing understanding that administering CAR T therapies to patients with low disease burden can improve safety and efficacy outcomes.

Zack: If alpha three a successful <unk> could become the standard seven cycle of frontline treatment available to all eligible patients with MLD.

Zack: Additionally, alpha three build on the growing understanding that administering car T therapies to patients with low disease burden can improve safety and efficacy outcomes.

Zachary J. Roberts: Semicell's Phase I safety profile with low rates of CRS and ICANs already permits its use in the outpatient setting in relapse-refractory patients and may further improve in patients with no radiological evidence of disease. The outcome of this pivotal trial could allow semicell to be embedded in the frontline setting where autologous therapies are far less feasible. Consolidating response following an MRD-positive result post-RCHOP requires immediate and definitive action to prevent an impending relapse.

Zack: <unk> phase one safety profile with low rates of Crs ni cans already permitted to use in the outpatient setting and relapsed refractory patients and may further improve in patients with no radiological evidence of disease.

Zack: The outcome of this pivotal trial could allow <unk> to be embedded in the frontline setting where autologous therapies are far less feasible.

Zack: <unk> response, following an Mardi positive result post R. Chop requires immediate and definitive action to prevent an impending relapse.

Zachary J. Roberts: Relapses tend to happen quickly after completion of RCHOP, in many cases within weeks to a few months, making the speed to treatment a critical factor in the success of a consolidation strategy like Alpha 3. Semi-cell treatment could begin within days following MRD test results. However, as we have seen, autologous CAR-Ts have had difficulty penetrating community cancer centers and accessing earlier-line patients.

Zack: Relapses tend to happen quickly after a completion of our chop in many cases within weeks to a few months, making the speed to treatment a critical factor in the success of our consolidation strategy like Alpha <unk> III.

Zack: <unk> treatment could begin within days following MRV test results as we have seen.

Zack: <unk> car Ts had difficulty penetrating community cancer centers and accessing earlier line patients.

Zachary J. Roberts: Use of Semicell won't rely on the complex logistics that have hindered CAR T adoption, nor will there be a reliance on referrals as the intent is for CAR T to be available in these community cancer centers. These doctors have been waiting for an allogeneic like Semicell to use CAR T in their centers. We believe autologous CAR T's, bispecifics, or any other treatment modality cannot reproduce the differentiated attributes of semicell. You can see what this journey looks like across modalities on slide eight.

Zack: Use of <unk> wont rely on a complex logistics that have hindered car T adoption, nor will there be a reliance on referrals as the intent is for car T to be available in these community cancer centers.

Zack: These doctors had been waiting for an allogeneic likes MSL to using car T. In their centers, we believe autologous car Ts bi specifics or any other treatment modality cannot reproduce the differentiated attributes of <unk> you.

Zack: You can see with this journey looks like across modalities on slide eight.

Zachary J. Roberts: Slide 14 provides greater granularity regarding what to expect during the Alpha 3 Pivotal trial. Startup activities for Alpha 3 are well underway and are nearing completion at several sites. In fact, we have completed the selection of nearly all clinical trial sites that include community-based cancer centers. The study will randomize approximately 240 patients who are MRD positive at the end of frontline therapy to either consolidation with semicell or the current standard of care, which is observation with serial clinic visits, blood draws, and CT scans.

Zack: Slide 14 provides greater granularity regarding what to expect during the Alpha <unk> III pivotal trial.

Zack: Startup activities for Alpha three are well underway and are nearing completion at several sites in.

Zack: In fact, we have completed the selection of nearly all clinical trial sites that include community based cancer centers.

Zack: The study will randomize approximately 240 patients who are <unk> positive at the end of frontline therapy to either consolidation with MSL or the current standard of care, which is observation with serial clinic visits blood draws and Cte scans.

Zachary J. Roberts: With the primary endpoint of event-free survival, the design will initially include two treatment arms that differ in the lymphodepletion regimen used. One arm will feature standard fludarabine and cyclophosisphamide plus ALO647, and the other arm will feature fludarabine and cyclophosisphamide alone without ALO647.

Zack: With the primary endpoint of event free survival. The design will initially include two treatment arms that differ in the lymphoid depletion regimen used one arm will feature standard Fludarabine and cyclophosphamide, plus allo 647, and the other fludarabine and cyclophosphamide alone without Allo 647.

Zachary J. Roberts: The first indication of how the trial is proceeding will be when we announce the selection of the lymphodepletion regimen that we will continue to use to the end of the trial. That announcement is expected in mid-2025. The next study milestones will come less than a year later. First, we expect to complete enrollment in the first half of 2026. And second, because the prognosis of patients who are MRD positive at the end of frontline therapy is quite poor, study events are expected to come in quickly, so we expect to perform efficacy analyses in 2026 as well.

Zack: The first indication of how the trial is proceeding will be when we announced the selection of the Olympia depletion regimen. We will continue to the end of the trial that announcement is expected in mid 2025.

Zack: The next study milestones will come in less than a year later first we expect to complete enrollment in the first half of 2026 and.

Zack: And second because the prognosis of patients who are <unk> positive at the end of frontline therapy is quite poor study events are expected to come in quickly. So we expect to perform efficacy analysis in 2026 as well.

Zachary J. Roberts: This will include an independent data safety monitoring board interim efficacy analysis in the first half of 2026 and the data readout of the primary EFS analysis in the second half of 2026. If the trial is successful, we expect to follow these data readouts with a biologic license application or BLA submission, targeted for 2027.

Zack: This will include an independent data safety monitoring board interim epic interim efficacy analysis in first half of 2026 and the data readout of the primary analysis in second half of 2026.

Zack: If the trial is successful we expect to follow these data readouts with a biologic license application or BLA submission.

Targeted for 2027.

Zachary J. Roberts: The outcome of this pivotal trial could allow SEMICEL to improve cure rates and become the only treatment approved for the consolidation of frontline treatment, potentially reducing the need for CAR-T in later lines and simplifying the decision about frontline treatment. Knowing an effective consolidation option exists could abrogate the need for complex regimens of five, six, or even more agents in newly diagnosed patients. On slide 19, we briefly look at the next key milestones for the Alpha 2 CLL cohort. There is strong scientific rationale to believe that an alocar T product derived from healthy donor cells could create a clinically meaningful advance for these late-stage patients with a one-time dose and simpler administration and logistics.

Zack: The outcome of this pivotal trial could allow us MSL to improve cure rates and become the only treatment approved for the consolidation of frontline treatment.

Potentially reducing the need for car T. In the later lines and simplifying the decision for frontline treatment.

Zack: Knowing and effective consolidation option exists could abrogate the need for complex regimens of five to six or even more agents in newly diagnosed patients.

Zack: On Slide 19, we briefly look at the next key milestones for the Alpha to CLO cohort.

Zack: There is strong scientific rationale to believe that an allo car T product derived from healthy donor cells could create a clinically meaningful advance for these late stage patients with a onetime dose and simpler administration and logistics.

Zachary J. Roberts: The Phase I cohort will include 12 patients treated with Semicel and is now enrolling patients. We expect to complete the Phase 1 trial enrollment and have an initial data readout by the end of this year. Based on the outcome of this trial, we would expect to move into a pivotal Phase 2 trial in 2025. The bar for this trial is modest, given that an autologous CAR-T therapy was recently approved with an overall response rate of 45% and a complete response rate of 20% in patients who received infusions at the target dose. Considering all those who underwent leukophoresis, the response rate and the complete response rate fell to 37% and 14%, respectively.

Zack: The phase one cohort will include 12 patients treated with <unk> and is now enrolling patients we expect.

Zack: To complete phase one trial enrollment and have an initial data readout by the end of this year.

Zack: Based on the outcome of this trial, we would expect to move into a pivotal phase III trial in 2025.

The bar for this trial is modest given that an autologous car T therapy was recently approved with an overall response rate of 45% and a complete response rate of 20% in patients who received infusions at the target dose.

Zack: Considering all of those who weren't Luke underwent leukapheresis. The response rate and the complete response rate fell to 37% and 14% respectively and.

Zachary J. Roberts: Importantly, for an off-the-shelf CAR T product candidate like Semicell, virtually all enrolled patients who have met all trial criteria are expected to receive an infusion. I want to turn your attention to slide 27 in our autoimmune program next. Allo329 is our wholly-owned, next-generation, site-specific integration-based, dual-targeting CD19, CD70 Allocar T. Our design is centered on both scalability and reducing or even eliminating lymphodepletion, which we believe is absolutely critical for rapid clinical development and future commercial success.

Importantly for an off the shelf car T product candidates like <unk> virtually all enrolled patients who have met <unk> criteria are expected to receive infusions.

Zack: I want to turn your attention to slide 27 in our autoimmune program next.

Zack: <unk> nine is our wholly owned next generation site specific integration based dual targeting CD 19, CD 70, Allo car T.

Zack: Our design is centered on both scalability and reducing or even eliminating limp for depletion, which we believe is absolutely critical for rapid clinical development and future commercial success.

Zachary J. Roberts: We are currently working on our IND-enabling manufacturing process and analytic assay development. We expect to file an IND in Q1 2025 and begin enrolling that trial in the first half of 2025. As a result, we expect to have proof of concept in this trial by the end of 2025. We recognize that the highest clinical proof of concept is in lupus, but as we have noted earlier, we also recognize the importance of differentiation, so we are considering other indications with unmet needs.

Zack: We are currently working on our IND, enabling manufacturing process and analytic assay development.

Zack: We expect to file an IND in Q1, 2025 and begin enrolling that trial in the first half of 2025.

Zack: As a result, we expect to have proof of concept in this trial by the end of 2025.

Zack: We recognized that highest clinical proof of concept is in lupus, but as we have noted earlier. We also recognize the importance of differentiation. So we are considering other indications with unmet need.

Zachary J. Roberts: Lastly, Slide 30 reviews our Phase 1 Traverse Trial Timeline for Allo 316. This quarter, we plan to detail what we believe to be a fundamental discovery, the algorithm that may mitigate the treatment-associated hyperinflammatory response without compromising the CAR-T function needed to eradicate solid tumors. The manuscript is currently undergoing peer review. A Phase I data update from approximately 20 patients with CD70-positive renal cell carcinoma is planned by year-end 2024.

Zack: Lastly, slide 30 reviews, our phase one traverse trial timeline for Allo 316.

Zack: This quarter, we plan to detailed what we believe to be a fundamental discovery. The algorithm that may mitigate the treatment associated hyper inflammatory response without compromising the car T function needed to eradicate solid tumors.

Zack: The manuscript is currently undergoing peer review.

Zack: Our phase one data update from approximately 20 patients with CD 70 positive renal cell carcinoma as planned by year end 2024.

Zachary J. Roberts: In totality, and as shown on slide 32, we have meaningful data flow between now and through 2026 that will demonstrate the potential of our program. We look forward to answering any additional questions you have about our pipeline during the Q&A. We'll now open the call to questions.

Zack: In totality and as shown on slide 32, we have meaningful data flow between now and through 2026 that will demonstrate the potential of our programs.

Speaker Change: We look forward to answering any additional questions you have on our pipeline during the Q&A, we'll now open the call for questions.

Operator: Thank you. Ladies and gentlemen, as a reminder to ask a question, please press star 1-1 on your telephone and then wait to hear your name announced. To withdraw your question, please press star 1 again.

Speaker Change: Thank you, ladies and gentlemen, as a reminder to ask a question. Please press star one on your telephone and then wait to hear your name announce.

Speaker Change: To withdraw your question. Please press star one again.

Operator: Please limit yourself to one question only. Please stand by while we compile the Q&A. Our first question comes from the line of Michael Yee with Jeffries. Your line is open.

Speaker Change: Please limit yourself to one question only.

Speaker Change: Please standby, while we compile the Q&A roster.

Speaker Change: Okay.

Speaker Change: Our first question comes from the line of Michael Yee with Jefferies. Your line is open.

Michael Jonathan Yee: Hey guys, congratulations on all the progress and, I guess, consolidation of everything. I think it speaks to the bullish nature of how you guys are looking at things. I know you want to keep it to one question, but I guess it's a two-parter.

Michael Jonathan Yee: Hey, guys. Congrats on all the progress and yes consolidation of everything I think.

Michael Jonathan Yee: Speaks to the bullish nature of how you guys are looking at things I guess.

Zachary J. Roberts: On the phase three that you're enrolling in consolidation, can you explain your visibility on enrollment sites and patient numbers? I know that was always a question for the later-line studies but also would be a meaningful question for these studies given some of the sites we've talked to are still trying to understand the protocol and the design of the study as you would be breaking new ground. So, I want to understand your confidence in that, and then part two of that is, what is the difference between the interim analysis and the full primary EFS analysis? Thank you.

Michael Jonathan Yee: I know you want to keep it to one question I guess, it's a two parter on the phase III that youre enrolling in consolidation can you explain your visibility on enrollment sites patient numbers.

Michael Jonathan Yee: That was always a question for the later line studies, but also would be a meaningful question for these studies given some of the sites. We've talked to are still trying to understand the protocol and the design of the study as you'd be breaking new ground. So I want to understand your confidence on that and then part two of that is what is the difference Virginia interim analysis and the primary analysis.

Zachary J. Roberts: Thanks, Michael. This is Zach.

Speaker Change: Thanks, Michael this is that good questions. So with respect to the first question, which I'll sort of relate to feasibility.

Michael Jonathan Yee: What we will what we can share is that the the interest in this program has been quite market both from academic as well as community based oncology centers we.

Zachary J. Roberts: Good questions. So, with respect to the first question, which I'll sort of relate to feasibility, what we can share is that the interest in this program has been quite marked, both from academic as well as community-based oncology centers. We expect to have approximately 50... 50 clinical trial sites open in the United States, and that will be a blend of community practices and tertiary care academic centers.

Michael Jonathan Yee: We expect to have approximately 50.

Michael Jonathan Yee: <unk> clinical trial sites open in the United States that will be a blend of community practices and tertiary care academic centers.

Zachary J. Roberts: And almost all of those sites have been selected, and we are on pace to activate our first batch of sites by the middle of this year to enable trial enrollment. So I would say that the enthusiasm from these clinical trial sites has been very, very high. Your second question around the difference between the interim and primary analyses in 2026, in the first half and second half respectively, relates to the number of EFS events that we will be assessing at the interim and the primary analysis.

Michael Jonathan Yee: And almost all of those sites have been selected and we are on pace to activate our first batch of sites by middle of this year to enable trial enrollment. So I would say that the enthusiasm from these clinical trial sites has been very very high.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Tyler Van Buren with TVCOLIN. Your line is open.

Michael Jonathan Yee: Your second question around the difference between the interim and primary analyses in 2026, and first half and second half respectively related to the number of Etfs events that we will be assessing at the interim and the primary analysis.

Operator: Please stand by for our next question. Our next question comes from the line of Tyler Van Buren with TVCOLIN. Your line is open.

Speaker Change: Thank you.

Speaker Change: Standby for our next question.

Zachary J. Roberts: Thanks, Tyler. I don't think that the concept of MRD has made its way into the general consciousness of the patient population yet. We do think that that is coming and will probably come quickly. But that's not the case for the investigators who have signed up for the trial. They all see the potential for this assay, and it has the potential to change practice. With respect to an individual patient and doctor conversation about whether to enroll in the study, we believe that this study will be highly attractive to patients because they'll be looking for an MRD negative result to tell them that they're likely cured of their malignancy.

Speaker Change: Our next question comes from the line of Tyler Van Buren with TD Cowen Your line is open.

Hey, guys, thanks for that and congrats on all the progress.

Speaker Change: So I believe the likelihood of the output three trials, succeeding is Super high frankly, so do patients appreciate the risk of being MRV positive after R chop or why wouldn't they choose to undergo this.

Speaker Change: Therapy in enrolling the trials.

Speaker Change: Thanks, Tyler so.

Tyler: I don't I don't think that the concept of MRV has made its way into.

Speaker Change: Sort of a general consciousness of the patient population yet we do think that that is coming in probably come quickly.

Speaker Change: That's not the case for the investigators who have signed up for the trial they all.

Speaker Change: See the potential for this assay and it's.

Speaker Change: Potential ability to change practice.

Speaker Change: With respect to an individual patient and doctor conversation about whether to enroll in the study. We believe that this in this study will be highly attractive to to the patients because they will be looking for in MRV negative result to tell them that they are likely cured of their of their malignancy now for those patients who are.

Zachary J. Roberts: Now, for those patients who are MRD positive, we also can't really understand why a patient wouldn't, at that point, jump at the chance to receive a dose of Semicell in consolidation for all the reasons that we've detailed. Importantly, there are no approved therapies right now available for patients who are in remission at the end of first line but remain MRD positive.

Speaker Change: MRV positive.

We also can't really understand why a patient would at that point jump at the chance to.

Speaker Change: Who received a dose of <unk> in consolidation for all the reasons that we've detailed importantly, there are no approved therapies right now available for patients who are in remission at the end of frontline, but remain positive. We believe that this will be a fairly significant competitive advantage for us during the enrollment.

Operator: We believe that this will be a fairly significant competitive advantage for us during enrollment and at the time of potential launch. Thank you. Please stand by for our next question. Our next question comes from the...

Speaker Change: <unk> and at the time of a potential launch.

Operator: Please stand by for our next question. Our next question comes from the line of Salveen Richter with Goldman Sachs. Your line is open. Good afternoon.

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

Our next question comes from the line of Salmon Ritzert with Goldman Sachs. Your line is open.

Good afternoon, Thanks for taking my question into.

Salmon Ritzert: Into the MSL data in Cielo until year end could you just help us understand what you would view as a positive outcome herein and where the clinical bar currently lies.

Zachary J. Roberts: Thanks, Salveen. You know, we think that the bar here is still quite low, as a matter of fact, and the unmet need here is only growing in this relapsed fractory CLL population. As we mentioned during the prepared remarks, a recent autologous CAR T product was approved with a fairly modest response rate and complete response rate. Importantly, we believe that the patients who derive benefit tend to do so fairly quickly following an infusion of CAR T cells.

Salmon Ritzert: Thanks Savi so.

Salveen Jaswal Richter: We think that the bar here is still quite low as a matter of fact in the unmet need here is only growing in this relapsed refractory <unk> population.

Salveen Jaswal Richter: As we as we mentioned during the prepared remarks recent autologous car T.

Savi: <unk> was approved on a fairly modest response rate and complete response rate importantly, we believe that that that the patients who derive benefit tend to do so fairly quickly following an infusion of car T cells. So fast forwarding now to the end of this year.

Zachary J. Roberts: So fast forwarding now to the end of this year, as we mentioned, we're enrolling the phase one cohort now, and we expect to have that data shared at the end of this year. Now, of course, there will be limited follow-up on those patients. However, we should be able to have a response rate and some modest follow-up on some of those patients, at least. So we expect that this data will be helpful for us as we're planning to make that go or no go decision for pivotal next year.

Savi: As we mentioned were enrolling the phase one cohort now and we expect to have.

Savi: That data.

Operator: Please stand by for our next question. Our next question comes from the line of Reni Benjamin with Citizens JMP. The line is open.

Savi: Sure at the end of this year now of course, there will be limited follow up on those patients. However, we should be able to have response rate and some modest follow up on some of those patients at least so we expect that.

Savi: This data will be helpful for us as we're planning to make that go no go decision for pivotal next year.

Thank you.

Speaker Change: Please standby for our next question.

Speaker Change: Our next question comes from the line of Reni Benjamin with citizens JMP. Your line is open.

David D. Chang: Hey, thanks for taking the questions, and congratulations on all the progress, especially getting the rights back. And that's my main question, mainly. Are you ready to move forward with semicell commercialization in Europe by yourself, or do you really feel that this is something that must be done with a partner? And I guess just related to that, in terms of manufacturing, is this something that you could do from here in the States and ship out, or do you feel that you would have to create a manufacturing facility in Europe? Thanks.

Reni John Benjamin: Hey, Thanks for taking the questions and congratulations on all the progress, especially.

Reni John Benjamin: Getting the right back on and Thats. My question, mainly are you ready to move forward with <unk> commercialization in Europe.

Reni John Benjamin: By yourself or do you really feel that this is something that must be done with a partner.

Reni John Benjamin: And I guess just related to that in terms of manufacturing is that something that you could do from here in the states and ship out or do you feel that you would have to.

Reni John Benjamin: Great manufacturing facility in Europe.

David D. Chang: So, Ren, this is Dave Chang. I'll let me answer that question. We are extremely excited to gain rights to the European Union and the UK. I mean, this is really big and increases the market potential of the semicell significantly. The two questions that you're asking, you know, the EU, you know, how ready we are, I mean, we just signed a deal, give us a little bit of a chance. I mean, this is something that we have done in our previous experiences to, you know, you know, conduct the clinical study and also prepare for, you know, regulatory filing and also for commercialization.

Reni John Benjamin: So Ryan this is Dave Chang, let me answer that question.

David D. Chang: Extremely excited to gain rights to European Union and U K I mean, this is really big.

David D. Chang: Increases the market potential of this MSR significantly.

David D. Chang: The two questions that you're asking the EU how ready we are I mean, we just signed the deal gave us a little bit of chance I mean, this is something that we have done.

David D. Chang: Previous experiences.

David D. Chang: Two.

David D. Chang: Place the clinical study and also prepare for regulatory filing and also for commercialization, but right now.

David D. Chang: But right now, you know, the ink is drying, so give us a little bit of time before we outline how we plan to expand in Europe. And as Geoff has also mentioned, this is also what I believe is an opportunity for partnership, which we believe can bring a significant upside to how much and how fast we can expand the program in Europe. The second question is a relatively simple one. I mean, we have our own manufacturing facility, CellForge1, across the bay. That's the San Francisco Bay.

David D. Chang: The ink is dry so give us a little bit of time before we outline how we plan to expand in Europe and as Jeff has also mentioned this is also what I believe as an opportunity for partnership, which we believe can bring us significant upside to how much and how fast we can expand the program.

David D. Chang: In Europe the <unk>.

David D. Chang: Second question.

David D. Chang: And that facility, from the beginning, was designed to meet clinical as well as commercial regulatory requirements for both US and Europe. And yes, you're absolutely right. We can manufacture the product there and ship it to Europe for clinical studies. Thank you. Please stand by for our next question, which comes from the line of Luca Issi with RBC Capital. Your line is open. Oh, great. Thanks so much for taking my question. Congratulations on all the progress.

David D. Chang: Pretty simple one I mean, we have our own manufacturing facility sell for each one across today, that's the San Francisco Bay and debt facility from the beginning was designed to meet.

David D. Chang: The clinical as well as the commercial regulatory requirement for both U S and Europe, and yes, you're absolutely right. We can manufacture the product there and ship it to Europe for clinical studies.

Operator: Please stand by for our next question, which comes from the line of Luca Issi with RBC Capital.

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

Speaker Change: Our next question comes from the line of Luca <unk> with RBC capital. Your line is helpful.

Operator: Your line is open. Oh, great. Thanks so much.

Luca: Great. Thanks, so much for taking my question Congrats on all the progress maybe quick one for us.

Operator: Maybe a quick one.

Luca: <unk> talked about the powering assumption in our plus three I think your prior corporate deck actually slagged eight months since the expected median PFS for the control arm, but I no longer see that in your new deck anything to read into that and also how youre thinking about immediate esn's cardiac D var.

Given you're actually never tested that product in that setting any call very much appreciate it. Thanks so much.

Zachary J. Roberts: Thanks, Luca. So we haven't. I've gone into details around the powering assumptions that we made for the overall study design. As you'll note, the sample sizes have remained consistent at 110 patients versus 110. As far as the timing of the EFS events on the control arm, so the eight months that we had previously featured really were counting from the initiation of our CHOP. And actually, it's probably somewhere between four to eight months, which will actually unfold in the context of the study. And that's based on a fair amount of research.

Speaker Change: Thanks, Luca so we haven't.

Speaker Change: Gone into details around the powering assumptions that we made for the overall study design as Youll note that the sample sizes has remained consistent to 110 patients versus 110 as far as the timing of BFS events on the control arm.

Speaker Change: So eight months that we had previously featured really was counting from the initiation of R chop and actually its probably somewhere between four to eight months for which will actually unfold in the context of the study.

Speaker Change: And Thats based on a fair amount of published literature for patients treated with R. Chop.

Zachary J. Roberts: That's the second question.

Speaker Change: The second question was.

Speaker Change: What we expect under control treatment.

Zachary J. Roberts: Yes, so as far as what we control for and what we're anticipating for the treatment arms, So again, this is gonna get back to the powering assumptions which we haven't guided to publicly. However, what we can say is that the experience that we have from the phase one program suggests that patients who achieve a CR do tend to do very well, and they tend to stay in CR. That's point number one.

Speaker Change: Yes, so as far as what we control for that.

Speaker Change: What we're anticipating for the treatment arm.

Speaker Change: So again this is going to get back to the powering assumptions, which we haven't.

Speaker Change: <unk> guided to publicly however, what we can say is that the.

Speaker Change: The experience that we have from the phase one program suggests that patients who.

Speaker Change: Who achieved a CR do tend to do very well and they tend to stay NCR. That's point number one and point number two.

Zachary J. Roberts: Point number two, I'll again refer to the growing body of literature to suggest that treatment with CAR T-cells at relatively low disease burdens does tend to lead to better efficacy outcomes. So while we don't have any hands-on experience in the MRD positive patient population, there is quite a bit of evidence to suggest that this actually will work quite well, and we'll be able to improve EFS significantly over the control arm.

Speaker Change: Again refer to the growing body of literature to suggest that treatment with car T cells at relative low disease burdens.

Speaker Change: Does tend to lead to better efficacy outcomes. So while we don't have any hands on experience in the <unk> positive.

Speaker Change: Patient.

Speaker Change: <unk>.

Speaker Change: There is quite a bit of evidence to suggest that this actually will work quite well and we'll be able to improve significantly over the control arm and.

David D. Chang: And Luca, let me just add by saying that this study is well-powered for EFS events as well as BFS, and I would just ask you to look at the sample size, you know, how big the study was in the second-line setting of Yaskara and Brianzi that led to a successful outcome and, essentially, brought forward a treatment that changed the practice.

David D. Chang: And, Luca, let me just...

Speaker Change: And look let me just add on by saying that this study is well powered for efficacy event as well as PFS and I would just ask you to look at this in a sample size how big the study was in the second line setting of the SCADA and choreography that led to a successful outcome.

Speaker Change: And essentially.

Speaker Change: Correct.

Speaker Change: Bringing forward a treatment that change the practice.

Speaker Change: Yes.

Operator: Please stand by for our next question. Our next question comes from Alana Astika with Truist. Your line is open.

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

Speaker Change: Our next question comes from the line of SD.

SD: <unk> with Truest your line is open.

Operator: Hi guys, thanks for taking my questions. And I'll also offer my congratulations on saving the rights to Semicel from Servier and the financing that you just announced. I'm going to do a spin-off on Tyler's question, and I share the same enthusiasm he does as well for Alpha 3.

SD: Hi, guys. Thanks for taking my questions and I'll also optimized congratulations on saving the rights of <unk> from Serbia, and financing, which and stuff, but just announced.

SD: I'm going to do a spinoff on Tyler's question and I share. The same enthusiasm you guys as well for alpha three but I'm going to also ask.

Zachary J. Roberts: But I'm going to also ask, given the confidence you're going to have in the active arm, what's going to compel a patient to stay on the control arm once they know that they're on the control arm there? And then I can squeeze another quick one in. In CLL, how much persistence is needed? We know with LBCL that upfront tumor killing is what's really important. What do we know about CLL right now in terms of how much persistence is really needed?

SD: Given given the confidence you're going to have and be active on whats going to compel a patient to stay on the control arm once they know that they've been better under control on that and then if I can squeeze in a quick one in.

In CLO, how much persistence is needed we know with L. Bcl upfront tumor, killing us what's really important what do we know about <unk> right now.

SD: In terms of how much persistence is very needed.

Zachary J. Roberts: Thanks, so coming back to the question on the patients who get randomized to the control arm, there are a couple of reasons that they would stay in the control arm.

Speaker Change: Thanks Africa, so coming back to the question on the patients who get randomized to the control arm. So.

Speaker Change: There's a couple of reasons that they would stay on the control arm.

Zachary J. Roberts: Putting my sort of patient hat on, I think it's going to be quite reassuring for them to know that they're being followed very closely in the context of a clinical trial, at least as closely as they would be followed under standard of care. And often, because the focus on getting patients into the clinic and so forth is so much higher in the context of a clinical trial, probably even closer follow-up. So if I'm a patient, knowing that I'm getting the standard of care but I'm going to be watched like a hawk, I think will go a long way to reassuring patients.

Speaker Change: Putting my sort of patient had on I think it's going to be quite reassuring for them to know that they are being followed very closely in the context of a clinical trial.

Speaker Change: At least as closely as they will be followed for standard of care and often because.

The focus on getting patients into the clinic and so forth. So forth is so much higher in the context of a clinical trial, probably even closer follow up so if I'm a patient knowing that I'm getting the standard of care, but im going to be walks like a hawk I think will go a long way to reassuring patients and then I'll reiterate that even if those patients decide.

Zachary J. Roberts: And then I'll reiterate that even if those patients decide to discontinue the clinical trial, it's not as though they can find a physician who is going to treat them for their MRD disease. They're still going to have to wait for a relapse. There are no approved therapies for patients who are in remission with LBCL currently. With the second question on CLL around persistence, I think the evidence is still developing there, and I think we have to sort of not dive too deep into that rabbit hole.

Speaker Change: I'd to discontinue on the clinical trial.

Speaker Change: It's not as though they can find a physician who is going to treat them for their MRV disease, Theres still going to have to wait for a relapse. There are no approved therapies for patients who are in remission with <unk> currently.

Speaker Change: With the second question on CLO around persistence I think the evidence is still developing there and I think we have to sort of not not.

Zachary J. Roberts: We do know that these cells need to be around for a period of time. We have been able to show in the context of LBCL that our cells can stay around for quite a number of months, in some cases for six months and beyond. So we do, with our current FCA-based lymphodepletion regimen, we create a nice window of persistence for these cells to get in there and eradicate tumors.

Speaker Change: Dive too deep into that rabbit hole, we do know that the cells need to be around for a period of time, we have been able to show in the context of of L. Bcl that ourselves can stay around four <unk>.

Speaker Change: Quite a number of months in some cases six months and beyond so we do with our with our current.

Speaker Change: CA based lymphoid depletion regimen, we create a nice window of persistence for these cells to get in there and eradicate tumor.

David D. Chang: And let me just add to that, you know, one comment which I would like to make since the questions about how well this study will enroll and, you know, how the patients will behave once they are enrolled in the study. I mean, you know, at this point, yes, we have not studied the study, but the study was designed with significant input from the KOLs, both academic-based KOLs as well as community-based KOLs, and their opinion was unanimous about the design of the study, the randomized design, as well as how to handle the control arm.

David D. Chang: And let me just add,

Speaker Change: And let me just add on that one comment, which I would like to make since the questions about.

Speaker Change: This study will enroll.

Speaker Change: How that patients will behave once they are enrolled in this study.

Speaker Change: At this point, yes, we have not studied the study but the study was designed with a significant input from the Kols, both academic based kols as well as the community based kols.

Speaker Change: And their opinion was unanimous about this design of this study the randomized design as well as in our <unk>.

David D. Chang: So, you know, in terms of how the investigators will support the conduct of the study, which we are relying a lot on given the enthusiasm that they have expressed, that's where we have a lot of comfort level about the projections that we are making about the study enrollment cadence.

Speaker Change: <unk> handled the control arm. So I think in terms of how the investigators will support.

Speaker Change: The conduct of the study, which we are relying a lot given the enthusiasm that they have express that's where we have a lot of comfort level about the projections that we're making but the study enrollment cadence.

Operator: Please stand by for our next question. Our next question comes from the line of Brian Chin with J.P. Morgan. Your line is open.

Speaker Change: Thank you.

Please standby for our next question.

David D. Chang: Yeah, Brian, let me take on that question. You know, again, as we have said, Allo329, the program that we are advancing in autoimmune, IMD is planned for the first quarter of 2025. And we're hoping to get the initial proof of concept communicated by the year end. The question of whether the lymphoid depletion is needed or not, this is something that we have thought through very carefully. Looking at the data that we have from ALO5018, this is our CD19 allogeneic CAR-T program, as well as ALO316, which is a CD70 CAR-T program where we have treated a number of patients with the renal cell carcinoma.

Our next question comes from the line of Brian Chen with Jpmorgan. Your line is open.

Brian Chen: Hey, guys. Thanks for taking our question on autoimmune Theres a question of whether <unk> depletion is essentially an optimizing car T expansion.

Brian Chen: Can you tell us your perspective on the likelihood of us.

Brian Chen: Completely eliminating landfill depletion.

Brian Chen: Some of the key factors in bringing that to reality.

Speaker Change: Yes, Brian let me take on that question again, as we have said.

Speaker Change: <unk> Creek two nine.

Speaker Change: Graham that we are advancing an odor immune.

Speaker Change: These planned for the first quarter of 2025, and we are hoping to get the initial proof of concept communicated by the year end.

Speaker Change: The question, whether the lymphoid depletion is needed or not this is something that we have thought through very carefully.

Speaker Change: Looking at the data that we have from Allo 501, eight this is our CD 19.

Speaker Change: Allogeneic car T program as well as our 316, which is a CD 70 car T program, where we have treated a number of patients with renal cell carcinoma.

David D. Chang: So combining those data together and looking at all the translational data that we have seen is very clear. When you have the dagger technology, allogeneic CAR-T cells expand remarkably well. And we know that in terms of how CAR-T behaves, it depends very much on the expansion capability of the CAR-T cells. So that's information number one. Number Two information is what we believe is necessary to reset the immune system in patients with autoimmune disorders.

Speaker Change: Combining those data together and looking at all the translational data that we have seen is very clear when you have the dagger technology allogeneic car T cells expand remarkably well.

Speaker Change: And we know that in terms of a car how car T behaves depends very much on the expansion and capability of the car T cells. So thats inflammation number one number two inflammation is what we believe is necessary to reset the immune system in patients with autoimmune disorders, we do not.

David D. Chang: We do not, and this is also the view of many KOLs as well; nobody believes persistence is required. One common theme is the depth of the depletion, initial depletion, that's important, but when we put all the information that we have together, we believe LO329 will expand well, and with that, we will achieve the deep depletion of B cells and activated T cells, and we believe that is critical to reset the immune system.

Speaker Change: And also this is the view of many kols as well nobody believes persistence is required.

Speaker Change: One common theme is the depth.

Speaker Change: Depletion initial depletion thats the important but when we put all of the information that we have together, we believe our <unk> III to nine will expand well and with that we will achieve the deep depletion of b cells and <unk>.

Speaker Change: Activated T cells, and we believe that is critical to reset the immune system.

Operator: Will you stand by for our next question? Our next question comes from the line of Sammy Corwin with Will Blair. Your line is open.

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Sammy Corwin with William Blair. Your line is open. Hey there, thanks for taking my question and congratulations on the progress.

Speaker Change: Our next question comes from the line of Sami Corwin with William Blair. Your line is open.

Samantha Danielle Corwin: Hey, there thanks for taking my question and congrats on the progress.

Wondering if you could clarify how many as the 240 or so patients being enrolled in alpha III will be enrolled initially in the three arms versus after the interim analyses and Melinda depletion selection and then just kind of curious why you.

Samantha Danielle Corwin: I did not to look at <unk> negativity as a secondary endpoint in that trial, just considering it does seem to be predictive of a long term question.

Zachary J. Roberts: Thanks, Sammy, great questions. So we haven't really gone into detail about how many patients are gonna be enrolled in that three-way randomization. However, we have said that the hypothesis testing sort of control arm versus treatment arm will take place on approximately 110 patients in each arm. So that can give you a little bit of an idea of how many additional patients we may need to enroll. It's a relative; it's a fraction of the overall enrollment.

Samantha Danielle Corwin: Yeah.

Speaker Change: Thanks, Amie great questions.

Speaker Change: So we haven't really gone into detail around how many patients are going to be enrolled in that three way randomization.

Speaker Change: However, we have told you have said that the hypothesis testing sort of.

Speaker Change: Control arm versus treatment arm will take place on approximately 110 patients in each arm.

Speaker Change: I can give you a little bit of an idea of how many additional patients we may need to enroll it's a relative.

Speaker Change: It's a fraction of the overall enrollment and that number was selected to give us that right blend of statistical power to make the decision well informed on safety and efficacy in translational outcomes, but yet not enroll a large number of patients who would then go on to receive an LD regimen that is not carried.

Zachary J. Roberts: And that number was selected to give us that right blend of statistical power to make the decision well-informed on safety and efficacy and translational outcomes, but yet not enroll a large number of patients who would then go on to receive an LD regimen that is not carried forward for the duration of enrollment. As far as the question on the secondary endpoint for MRD, we will be examining this MRD clearance as an exploratory endpoint.

Speaker Change: Forward through the duration of enrollment.

Speaker Change: As far as the question on secondary endpoint for MRV.

Speaker Change: We will be examining this MRV clearance as an exploratory endpoint however.

Zachary J. Roberts: However, it probably didn't make a lot of sense to do it as a key secondary endpoint given that we were using the very same test to select the patients for enrollment in the first place. We are quite excited by the potential future for MRD clearance as a key endpoint in clinical trials, but we thought it best to stick to traditional endpoints like EFS for this phase three, phase two trial.

Speaker Change: It probably didn't make a lot of sense to do it as a key secondary endpoint given that we were using the very same task to select patients for enrollment in the first place.

Speaker Change: We are quite excited by the potential future for MRV clearance as as a.

Speaker Change: Key endpoints in clinical trials, but we thought it best to stick to the traditional endpoints like Etfs for this for this phase III phase II trial.

Operator: Please stand by for our next question. Our next question comes from the line of Jack Allen with Baird. Your line is open.

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

Speaker Change: Our next question comes from the line of Jack Allen with Baird. Your line is open.

Operator: Great, thanks so much. Congratulations to the team on all the progress. I wanted to ask about CellForge1. Are you planning on producing the material for Alpha 3 from CellForge1 and Alpha 2 for CLL patients? And then, as we look out on Alpha 3 and the reacquisition of global rights, or the acquisition of global rights, I should say, for ILL501A, could Alpha 3 become a global study, in your view, or are you really committed to running that solely in the U.S.?

Jack Kilgannon Allen: Great. Thanks, so much and congratulations to the team on all the progress I wanted to ask about self order one.

Jack Kilgannon Allen: Are you planning on producing the materials for Alpha three from <unk>, one alpha to the CLO patients and then as we look out on office three and the acquisition of global rights or the acquisition of overnight I should say.

Jack Kilgannon Allen: For Allo 501.

Jack Kilgannon Allen: Could offer three become a global study in your view are you really are committed to running that so in the U S.

David D. Chang: Jack, both are great questions. The Self-Forge one, you know; this is our GMP facility. And that is fully operational, and it's producing GMP materials that are necessary for us to conduct both CLL and OPT-3 studies. In terms of, you know, what we do with the clinical supply, I mean, that's something that, you know, we don't go into the details. And you know, the second question, Jack, can you just remind us of the second question?

Speaker Change: Jackpot that great questions.

Speaker Change: South towards one.

Speaker Change: As our GMP facility.

Speaker Change: That is fully operational and it's producing GMP materials.

Speaker Change: <unk> plus to conduct both cielo and <unk> III study incomes.

Speaker Change: What we do with our clinical supply I mean, that's something that we don't go into the details and the second question.

Speaker Change: Jack can you just remind us the second question.

Operator: I was asking about the reacquisition of the rights. It sounds like someone's just reminded you.

Jack Kilgannon Allen: Yes, I was asking about the acquisition of the right type of excellence for Monday, So yes.

David D. Chang: Yeah, so in terms of the rights that we have obtained from Serbia, we have rights to Europe and the UK. And obviously, with that, we are very interested in expanding the clinical trial footprint as we prepare to commercialize in these extended territories. So on that, you know, as I said, we just signed the deal. So I would ask you to stay tuned. We'll provide more information on what we are doing in those territories at a later date.

Jack Kilgannon Allen: Terms of right that we have obtained from.

Jack Kilgannon Allen: Serbia is rights to Europe, and the U K and obviously with that we are very interested in expanding the clinical trial footprint as we prepare about commercializing in these extended territory so on that.

Jack Kilgannon Allen: As I said, we just signed the deal. So I would ask you to stay tuned we will provide more information on what we are doing in those territories in a future time.

Operator: Will you stand by for our next question? Our next question comes from the line of John Newman with Canaccord. Your line is open.

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

Speaker Change: Our next question comes from the line of John Newman with Canaccord. Your line is open.

Operator: Hi Guys, I'd like to add my congratulations on all the progress as well.

John Lawrence Newman: Hi, guys.

John Lawrence Newman: Congrats on all the progress as well I had a question about <unk> nine in the autoimmune setting.

John Lawrence Newman: Some of your competitors are rolling studies in the autoimmune area, but theyre, including dermatomyositis patients or they're running separate studies my question is.

Zachary J. Roberts: I had a question about L329 in the autoimmune setting. Some of your competitors are rolling studies in the autoimmune area, but they're including dermatomyositis patients, or they're running separate studies. My question is, Are you considering including those patients in your study, and might there actually be an interesting filing strategy there, given that it's an orphan disease?

John Lawrence Newman: Are you considering including those patients in your study and.

John Lawrence Newman: They are actually be.

And interesting filing strategy there given that.

John Lawrence Newman: Orphan disease.

Zachary J. Roberts: Thanks, John. I think I'll ask you to stay tuned for further details on the clinical development plan as we kind of get a little bit closer to the IND submission. As we mentioned in the prepared remarks, we're going to be looking carefully at the existing proof of concept out there, but also looking for opportunities for differentiation in the development plan. So please stay tuned.

Speaker Change: Thanks, John I think I'll ask you to stay tuned for further details on the clinical development plan as we kind of get a little bit closer to the IND submission as we mentioned in the prepared remarks, we're going to be looking carefully at the existing.

John Lawrence Newman: Proof of concept out there, but also looking for opportunities for differentiation in the development plan. So please stay tuned.

David D. Chang: And John, let me just add, Allo329 is a very exciting program. There's a lot of interest, and once, you know, we obtain the proof of concept, this is also a program that can expand into many different indications in the autoimmune space. That includes not only indications where CAR-T has proven, you know, initial proof of concept, but also indications where the T cell component may play a bigger role.

Speaker Change: And John Let me just add on I mean allo three to 90 is a very exciting program. There is a lot of interest.

Speaker Change: Yes.

Speaker Change: We obtained the proof of concept. This is also a program that can expand into many different indications in autoimmune.

Speaker Change: <unk>.

Speaker Change: That includes not only the indications where car T is proven.

Speaker Change: Initial proof of concept, but also indications where the T cell component may play a bigger role.

David D. Chang: As a reminder, you know, one of the key innovations and differentiations that we introduced into Allo329 is having a dual CD70, CD19, and the CD70 component has the ability to bring the dagger biology, as we have just talked about, but also address the activated T cells, which we believe have a pretty important role in the pathogenesis of autoimmunity.

Speaker Change: As a reminder.

Speaker Change: One of the key innovation and differentiation that we introduced into our three to nine is having a deal of CD 70, <unk> 19 in the CD 70 component has.

Speaker Change: <unk> to bring the dagger biologists, we have just talked about but also addressed the activated T cells, which we believe has a pretty important role in the pathogenesis of autoimmunity.

Speaker Change: Yes.

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

Operator: Please stand by for our next question. Our next question comes from the line of Kalpit Patel with B Rally. Your line is open.

Speaker Change: Our next question comes from the line of Kao pit.

Kalpit R. Patel: <unk> with B Riley your line is open.

Kalpit R. Patel: Yeah, Hey, thanks for taking the question.

Kalpit R. Patel: And this is sort of related to an earlier question, but do you think youll need multiple doses of allo 329, initially to get that profound b cell depletion that we have seen with auto car Ts.

B Riley: Autoimmune diseases since you're planning to reduce the dose of <unk>.

B Riley: Or the use of liquid depletion.

Operator: Let me take that question. We are not; we are planning to rely on single infusions to maximize the benefit of Allo 3 to 9.

Speaker Change: Let me take that question. We are not we are planning to rely on single infusion to maximize the benefit of our three Tonight.

Speaker Change: Thank you.

Operator: Please stand by for our next question. Our next question comes from the line of Samantha with Citi. Your line is open.

Operator: Thank you. Please stand by for our next question. Our next question comes from Alana Samantha with Citi. Your line is open.

Speaker Change: Please standby for our next question.

David D. Chang: Thank you. Yes. Samantha, you know, a great question. Let me take that question.

Speaker Change: Our next question comes from the line of Samantha with Citi. Your line is open.

Samantha: Hi, Thanks, very much for taking the questions just on Allo 302009, given you have the dual targeting approach how are you thinking about the potential answer the treatment associated hyper inflammatory response that you observed in the <unk> study with a diagnosis diagnostic and treatment algorithm that you developed is that applicable to our NIM.

Samantha: Population as well and can you just characterize a bit how you think the side effects might be BSI rheumatologists.

Speaker Change: Yes, Samantha Great question, let me take that question.

David D. Chang: You know, we have, you know, extensively reviewed the data that we have generated with the, you know, Allo 316 program where we are, you know, we have seen, you know, remarkable cell expansion after infusion. And like any CAR-T, when there's a great cell expansion, there is a hyperinflammatory response that follows. That's really the pharmacodynamic effect of Allo 329, which we intend to leverage heavily. How we see it is, you know, to address those questions is one way to do it is, you know, not go up on the high cell dose.

Samantha: We have extensively reviewed the data that we have generated with our <unk> six program, where we are.

Samantha: Yes.

Samantha: We have seen remarkable.

Samantha: Sal expansion after infusion and like any car T. When theres a great solid expansion. There is hyper inflammatory response that follows that is really the pharmacodynamic effect of our three Tonight, which we intend to leverage heavily how we see it is to address those questions.

Samantha: Is one way to do it is not go up on the high cell dose.

David D. Chang: And, you know, when we think about the autoimmune space, this is a pretty large indication, and the scalability of cell therapy is seen as a very critical issue. So this is a situation where, you know, Allo 329 from the manufacturing perspective and others can provide the number of patients that can meet the demand for autoimmune programs. So, if anything, the expansion capability that may come with Allo 329 will be leveraged to increase the, you know, the capacity with which we can expand autoimmune programs with Allo 329.

Samantha: And when we think of the autoimmune space.

Samantha: This is a pretty large indication in.

Samantha: Scale ability of the cell therapy is we view as a very critical issue. So this is a situation where our 329 from the manufacturing perspective than others.

Samantha: <unk> provide the number of patients that can meet the demand of autoimmune space. So if anything the expansion capability that may come.

Samantha: Come with Atlas III, two nine will be leverage to increase the capacity with which we can expand autoimmune programs with our three tonight.

Operator: Please stand by for our next question. Our next question comes from the line of Kelsey Goodwin with Guggenheim. Your line is open.

Thank you.

Speaker Change: Please standby for our next question.

Our next question comes from the line of Kelsey Goodwin with Guggenheim. Your line is open.

Kelsey Beatrice Goodwin: Oh, Hey, Thanks for taking my question and congrats on all the progress.

Kelsey Beatrice Goodwin: 4316, I guess, maybe could you just remind us the efficacy benchmark in RCC and what you'd need to see at the end of the year in order to advance. This program further thank you.

Zachary J. Roberts: Thanks, Kelsey. However, the RELASS refractory RCC outcomes are still quite poor. There's been a recent approval there, but it didn't really make much headway in terms of response rate or durability response over existing third-line agents approved here. So, we think that that bar is still quite low. Some of the response rates, somewhere around 20%, is the benchmark that we're looking at from the literature. And, as you recall, and when we shared data back at ACR last year, we were above that with a 30% response rate in patients whose tumors were known to express CD70. So, we're pretty encouraged by that early sign of efficacy.

Speaker Change: Thanks Kelcey so.

Speaker Change: The relapsed refractory RCC.

Speaker Change: Outcomes are still quite poor there has been a recent approval there however didn't really.

Speaker Change: Much headway in terms of response rate or durability of response over existing third line agents approved here. So we think that that bar is still quite low some of the response rate somewhere around 20% is what.

The benchmark that we're looking at from the literature.

Speaker Change: And as you recall.

Speaker Change: And when we share data back at ACR last year, we were above that with a 30% response rate in patients whose tumors were known to express CD 70, So we're pretty encouraged by that early sign of efficacy.

Operator: Will you stand by for our next question? Our next question comes from the line of Laura Prendergast with Raymond James. Your line is open.

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

Our next question comes from the line of law Prendergast with Raymond James Your line is open.

Laura Anne Prendergast: Hey, guys. Thanks for taking all the questions.

Laura Anne Prendergast: One for me just thinking about barriers for the community Center.

Laura Anne Prendergast: Our readiness for Thomas I'll, let Marty testing versus what you might see at the academic center.

Laura Anne Prendergast: And do you anticipate there.

Zachary J. Roberts: Thanks, Laura, for that question. I'll start by saying that, on the contrary, actually, what we're finding is these centers that we're approaching, these community centers, even those without hands-on CAR-T experience, are extremely well-equipped to run this trial. And that's because these docs have been giving bispecifics to patients now for several months for this indication, and of course, bispecifics for other indications as well. And so the toxicity profiles and the unique adverse events that T-cell-directed therapies share across different modalities have given both us and these doctors confidence that they'll be able to handle the patients that are being treated on this trial.

Speaker Change: Thanks, Laura for the for that question.

Speaker Change: I'll start by saying that.

Speaker Change: To the contrary actually what we're finding is these the centers that we're approaching these community centers, even though is without hands on car T experience R. R.

Speaker Change: Extremely well equipped to run this trial.

Speaker Change: And that's because these these docs have.

Speaker Change: <unk> been giving by specifics to patients now for several months for this indication of course by specifics for other indications as well and so.

Speaker Change: The toxicity profiles and the unique adverse events.

Speaker Change: That T cell directed therapies share across different modalities, I think has given both us and the stocks confidence.

Speaker Change: That they'll be able to.

To handle the patients that are treated on this trial of.

Zachary J. Roberts: Of course, there is another category of barrier that I think has kept these centers from jumping into CAR T over the last decade, and that is a lot of the operational and logistical barriers that they just have not been willing to overcome at their centers. Because Semicel is off the shelf, it's shipped on demand, and in many cases, can be administered as an outpatient, all of those logistical and operational barriers that these centers face go away. And so, in fact, what we have found is actually quite an open and enthusiastic set of partners, even those who don't have direct hands-on CAR T experience.

Speaker Change: Of course, there is another category of barrier that I think has kept these centers from jumping into car T. Over the last decade and that is a lot of the operational and logistical barriers that they just have not been willing to undertake at their centers.

Speaker Change: Because <unk> is off the shelf it's shipped on demand.

Speaker Change: And in many cases can be administered as an outpatient all of those logistical and operational barriers that these centers face go away and so in fact, what we what we have found is actually quite an open and.

Enthusiastic set of partners, even even in those who don't have direct hands on car T experience.

Thank you.

Speaker Change: Please standby for our next question.

Operator: Please stand by for our next question. Our next question comes from the line of Ben Burnett with Stiefel. Your line is open.

Speaker Change: Our next question comes from the line of Ben Burnett with Stifel. Your line is open.

Operator: Hi, good afternoon. This is Carolina Ibanez-Dentoso from DenBurnett.

Ben Burnett: Hi, Good afternoon. This is currently nine vintage.

Operator: Thank you for taking our question. First, in the ALPHA-3 trial, will you do a second MRD assessment after lymphodepletion but before the administration of SEMA cell? And then, separately, given that ALLO316 and ALLO329 are based on the DIAGAR technology, would it be fair to look at the clinical updates from the TRAVERSE trial later this year as a window for the initial safety expected with ALLO329? Thank you.

So Ben Burnett, Thank you for taking our question.

Ben Burnett: First and they also have to be trial.

Ben Burnett: When you do a second <unk>.

Ben Burnett: The assessment after depletion, but before the administration of say Marcel.

Ben Burnett: And then separately given that im not saying 1639 are based on <unk> technology.

Speaker Change: Would it be fair to look at the clinical update from the trial later this year as a window for the initial safety aspect of it.

Speaker Change: Thank you.

Zachary J. Roberts: Thanks, Carolina. So the first question, we tend to avoid going into specifics around the timing of the assessments that we'll be performing in the clinical trial. I will say that the dynamics of MRD, generally speaking, are such that it does not tend to be a test that will turn negative in a matter of five days because the tumor is still there and not likely to be cleared in that short window of time.

Speaker Change: Thanks Carolina.

Speaker Change: So the first question.

Speaker Change: We tend to avoid going into specifics around the timing of the assessments that will be performing in the clinical trial I will say that the dynamics of MRV generally speaking are such that it does not tend to be a test that will will turn negative in the matter of five days because the.

Speaker Change: Tumor is still.

Speaker Change: Still there and not likely to be cleared in that short window of time so.

Zachary J. Roberts: So the utility of such an assessment would be questionable. The second question that you asked was around whether the efficacy update that we will share later this year from TRAVERSE will offer a window to potential efficacy or outcomes in 3.29. I'll say that we looked very carefully at the biology of 3.16 in the TRAVERSE trial as we were designing Allo3.29 specifically for an AID population. And we believe very strongly in the Dagger biology and the ability to propel these cells to good engraftment and persistence.

Speaker Change: The utility of such an assessment would be questionable.

Speaker Change: The second question that you asked was around whether the efficacy update that we share later this year from traverse.

Speaker Change: I'll offer a window to potential efficacy or outcomes and three to nine.

Speaker Change: Say that.

We looked very carefully at the biology of 316 in the traverse trial as we were designing allo <unk> specific for an AIB population and we believe very strongly in the dagger biology, and the ability to to propel these cells too good and graph and persistence.

Zachary J. Roberts: I wouldn't go much farther than that. I think the requirements for self-persistence are different in AID versus oncology. This is a dual-targeting car versus a single-targeting car. So I think there are sufficient differences in construct design and patient population that I don't think it's going to be all that instructive for us to scrutinize the 316 results and read into 329.

Speaker Change: I wouldn't go much farther than that I think.

Speaker Change: The requirements for cell persistence are different in AIB versus oncology. This is a dual targeting car versus a single target single targeting car. So that I think there are sufficient differences and construct design and patient population that I don't think it's.

Speaker Change: All of that it's going to be all that instructive for us to scrutinize the $3 six results in and read into 329.

Operator: Ladies and gentlemen, I'm showing no further questions in the queue. I would now like to turn the call back over to management for any additional comments.

Speaker Change: Thank you.

Speaker Change: Ladies and gentlemen, I'm showing no further questions in the queue I would now like to turn the call back over to management for any additional comments.

David D. Chang: Yeah, thank you, operator. We are very proud of how we continue to strengthen Allogene on all fronts and make sure we remain competitive today and in the future. We will continue to focus all our resources on advancing our core program, and with today's announced financing, we are well positioned to extend the cash runway for important data readout. And more importantly, we believe we are well-positioned to change the CAR T treatment landscape for the benefit of patients. Our thanks to you for joining us on the call today and our sincerest gratitude to our investors for your continued support. Operator, you may now disconnect.

Speaker Change: Yes, thank you operator.

Speaker Change: We are very proud of how we continue to strengthen allergen on all fronts and making sure we remain competitive today and in the future.

Speaker Change: We will continue to focus all our resources on advancing our core program.

Speaker Change: With today's announced financing we are well positioned to extend the cash runway into important data readout.

Speaker Change: And more importantly, we believe we are well positioned to change the car T treatment landscape for the benefit of patients.

Speaker Change: Our thanks to you for joining us on the call today, and our sincerest gratitude to our investors for your continued support operator, you may now disconnect.

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

Speaker Change: Ladies and gentlemen that concludes today's conference call. Thank you for your participation you may now disconnect.

Speaker Change: Okay.

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