Q2 2024 Allogene Therapeutics Inc Earnings Call

August 7, 2024

Okay.

Operator: Hello, and thank you for standing by. Welcome to Allogene Therapeutics' second quarter 2024 conference call.

Operator: Hello, and thank you for standing by.

Operator: Thank you for standing by. Welcome to Allogene Therapeutics' second quarter 2024 conference call.

Hello, and thank you for standing by.

Operator: Welcome to Allogene Therapeutics' second quarter 2024 conference call. At this time, all participants are going to listen-only mode. After the speaker's presentation, there will be a question-and-answer session.

Speaker Change: Welcome to allergy and Therapeutics second quarter 2024 conference call.

Operator: 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 11 on your telephone. You will then hear an automatic message advising your hand is raised. To withdraw your question, please press star 11 again. I would now like to turn the call over to Christine Cassiano.

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

After the Speakers' presentation, there will be a question and answer session.

Operator: To ask the question during this session, you will need to press Star 11 on your telephone. You will then hear an automatic message advising your hand is raised. To withdraw your question, please press star 11 again.

Ask a question during this session you will need to press star one on your telephone.

Speaker Change: You would then her automated message advising you had this race.

To withdraw your question. Please press star one again.

Christine Cassiano: I would now like to turn the call over to Christine Cassiano. You may begin.

I would now like to turn the call over to Christine Catriona.

Christine Catriona: 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 the business update and financial results for the second quarter of 2024. This press release and today's webcast are available on our website.

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 second quarter of 2024.

Christine Catriona: Thank you operator, and welcome to Aqua joined this call. After the market closed today allergy and issued a press release that provides a business update and financial results for the second quarter of 2024.

Christine Cassiano: This press release and today's webcast are available on our website. Following our prepared remarks, we will host a Q&A session. We recognize that, historically, questions have been multifaceted, but note that we will endeavor to keep this call to under an hour. 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: This press release and today's webcast are available on our website. Following our prepared remarks, we will host a Q&A session. We recognize that questions historically have been multifaceted, but note that we will endeavor to keep this call to under an hour. 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.

Speaker Change: Yes released from today's webcast are available on our website.

Christine Cassiano: Following our prepared remarks, we will host a Q&A session. We recognize that historically, questions have been multifaceted, but note that we will endeavor to keep this call to under an hour.

Speaker Change: Following our prepared remarks, we will host a Q&A session. We recognize that historically questions have been multifaceted, but note that we will endeavor to keep this call to under an hour.

Speaker Change: Joining me today are Dr. David Chang, President and Chief Executive Officer, Dr. Zachary, Robert Executive Vice President of research and development and Chief Medical Officer, and Geoff Parker, Our Chief Financial Officer.

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, commercial market forecast, 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 the 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 Allogene disclaims any obligation to update these statements. I'll now turn the call over to David. Thank you.

Speaker Change: During today's call, we will be making certain forward looking statements may include statements regarding the success and a tightening 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 commercial market forecast in 'twenty 'twenty four five.

Speaker Change: Cancel guidance among other things.

Speaker Change: These forward looking statements are based on current information assumptions and expectations that are subject to change a description of the potential risks can be found in our press release, our latest SEC disclosure documents.

Christine Cassiano: The description of the potential risks can be found in our press release and latest SEC disclosure documents. Your caution not to place under reliance on these forward-looking statements and the alleging explains any obligation to update these statements.

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

David Chang: I'll now turn the call over to David. Thank you, Christine, and welcome to those on the call today. We hope you all enjoy the pleasant summer so far. As I think about the first half of 2024 for Halogen, the word that continually comes to mind is momentum. Earlier in 2024, we reset the clinical development plan by advancing semicell, our lead CD19 alokarty product into an LBCL first-line consolidation study, and announced our decision to develop and advance the next generation alokarty product. Alok 329 into autoimmune indications, thereby placing Halogen in an enviable position of having clinical programs in team malignancies, solid tumors, and autoimmune indications.

David Chang: Thank you, Christine, and welcome to those on the call today. We hope you've all enjoyed a pleasant summer so far.

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

David: We hope you all enjoyed a pleasant summer so far.

David Chang: As I think about the first half of 2024 for Allogene, the word that continually comes to mind is momentum. Early in 2024, we reset the clinical development plan by advancing Semicell, our lead CD19 alocarti product, into an LBCL first-line consolidation study and announced our decision to develop and advance our next-generation Alokarti product, ALO329, into autoimmune indications. Therefore placing Allogene in an enviable position of having clinical programs in key malignancies, solid tumors, and autoimmune indications. Hard work creates opportunities, but external factors must line up to create and build momentum. As we think about the two programs we get asked about most often, Alpha 3 with SEMICEL and L329 in autoimmune.

David Chang: As I think about the first half of 2024 for Allogene, the word that continually comes to mind is momentum. Early in 2024, we reset the clinical development plan by advancing Semicell, our lead CD19 alocarti product, into an LBCL first-line consolidation study and announced our decision to develop and advance our next-generation Alokarti product, ALO329, into autoimmune indications. Therefore placing Allogene in an enviable position of having clinical programs in heme malignancies, solid tumors, and autoimmune indications. Hard work creates opportunities, but external factors must line up to create and build momentum. As we think about the two programs we get asked about most often, Alpha 3 with SEMICEL and L329 in autoimmune.

David: As I think about the first half of 2020 full flight housing toward that continually comes to mind is momentum.

Speaker Change: Early in 2024, we reset the clinical development plan by advancing <unk>, our lead CD 19, Allo car T products into <unk>.

David: First time consolidation study.

Speaker Change: And announced our decision to develop.

David: As a next generation Allo car T product.

David: Our three tonight into auto immune indications.

David: Thereby placing allergen in an enviable position.

David: Having clinical programs in heme malignancies, and solid tumors and autoimmune indications.

David Chang: Hard work creates opportunities, but external factors must line up to create and build momentum. As we think about the two programs, we get asked about most often Alpha three with Semicell and Alok 329 in Autoimmune momentum is on our side. To be clear, this does not mean that it has been easy. Our team is working harder than ever. But that same hard work and dedication, along with the bold choices we made over the last year, set up a chain reaction that we see daily as we work with investigators and external stakeholders on our program. Williams, simply put, the reset that was based on our long-standing conviction on our alo-cardi programs has put us in a position to potentially change the cardkey landscape.

Speaker Change: Hard work creates opportunities, but external factors must lineup to create and build momentum.

David: As we think about the two programs we get asked about most often.

Speaker Change: Factory with <unk> and Allo three to nine in autoimmune momentum is on our side.

David Chang: Momentum is on our side. But to be clear, this does not mean that it has been easy. Our team is working harder than ever. But that same hard work and dedication, along with the bold choices we've made over the last year, have set off a chain reaction that we see daily as we work with investigators and external stakeholders on our program. Simply put, the reset, that was based on our long-standing conviction in our Alok Karthi programs, has put us in a position to potentially change the Karthi landscape. Momentum, for us, is merely the starting point.

David Chang: Momentum is on our side. But to be clear, this does not mean that it has been easy. Our team is working harder than ever. But that same hard work and dedication, along with the bold choices we've made over the last year, have set off a chain reaction that we see daily as we work with investigators and external stakeholders on our program. Simply put, the recess, that was based on our long-standing conviction in our Alok Karthi programs, has put us in a position to potentially change the Karthi landscape. Momentum, for us, is merely a starting point.

David: To be clear this does not mean that it has been easy our team is working harder than ever.

David: But that same hard work and dedication along with the board choices. We've made over the last year set up a chain reaction that we see daily as we work with investigators and external stakeholders on our programs.

David: Simply put we set.

David: That was based on our longstanding conviction on our car T programs.

David: Obviously in a position to potentially change the car T landscape.

David Chang: Momentum for us is merely a starting point. Now that we have shifted strategy into a clear and honorable leadership position, our programs continue to build speed, and it has been remarkable for our lead program of a three.

David: Momentum for us is merely a starting point.

David Chang: Now that we have shifted strategy into a clear and honorable leadership position, our programs continue to build speed, and it has been remarkable for our lead program, Alpha 3. I will spotlight three measures that may not be as visible to investors as they are to us internally at Allogene. First, while the market is not kind to biotech right now, we strengthened our base of investors in this last round with some of the highest-caliber investors any company could hope for. But we don't take that for granted.

David: Now that we have shifted strategy into a clear and <unk> leadership position.

David: <unk> continues to build speed and it has been remarkable for our lead program <unk>.

David Chang: Our spotlight: three measures that may not be as visible to investors as they are to us internally at Allogene. First, while the market is not kind to buy tech right now, we strengthened our base of investors in this last round with some of the highest caliber investors any company could hold for. We don't take that for granted. Second, the number of sites who want to participate in our alpha three trial and the energy with which they are engaged can be likened to what we saw in the early days of Othala's Carti. There seems to be on the current of understanding that this trial has the potential to forever change their practices.

David Chang: Second, the number of sites who want to participate in our Alpha 3 trial and the energy with which they are engaged can be likened to what we saw in the early days of Othello's CAR-T. There seems to be an undercurrent of understanding that this trial has the potential to forever change their practice. Third, the collaborative engagement from the FDA on this trial has been illuminating. We believe we have achieved support for Alpha 3 based on three key benefits that stem from the innovative study design.

Speaker Change: Our spotlight three measures that may not be as visible to investors as they are to us internally at Alexander.

Speaker Change: First while the market is that trying to biotech right now we strengthened our base of investors in this last round with some of the highest caliber investors any company could hope for we.

Speaker Change: We don't take that for granted.

Speaker Change: Second the number of sites, who want to participate in our offer to a trial and the energy with which theyre engaged can be likened to what we saw in the early days of what kind of car T.

Speaker Change: There seems to be under current of understanding that this trial has the potential to forever change their practices.

David Chang: Third, the collaborative engagement from the FDA on this trial has been illuminating. We believe we have achieved support for alpha three based on three key benefits that stem from the innovative study design. One, advancing Carti into early line setting maximizes the curative potential of the variability. Two, treating minimum residual disease or MRD, the lowest disease volume one can measure, has the potential to make Carti safer and more effective. And three, using MRD to select and treat only the patient who will likely experience recurrence makes alpha three design very efficient. Concentrating treatment in only the patient population who needs it and leaving everybody else alone.

Speaker Change: Third to collaborative engagement from the FDA on this trial has been eliminated.

Speaker Change: We believe we have achieved support for Africa based on three key benefits that stemmed from the innovative study design.

David Chang: One, advancing CAR-T into early-aligned settings maximizes the curative potential of the modality. Two, Treating minimum residual disease, or MRD, the lowest disease volume one can measure, has the potential to make CAR-T safer and more effective. And three, using MRD to select and treat only the patient who will likely experience recurrence makes Alpha 3 design very efficient, concentrating treatment on only the patient population who need it and leaving everybody else alone.

David Chang: One, advancing CAR T into early-aligned settings maximizes the curative potential of the modality. Two, Treating minimum residual disease, or MRD, the lowest disease volume one can measure, has the potential to make CAR T safer and more effective. And three, using MRD to select and treat only the patient who will likely experience recurrence makes Alpha 3 design very efficient, concentrating treatment on only the patient population who need it and leaving everybody else alone.

Speaker Change: One advanced in car T into earlier line settings, maximize the security of potential with Audi.

Speaker Change: Two trading minimal residual disease or MRV to last at least volume one can measure has the potential to make car T safer and more effective.

Speaker Change: And three using mrna to select and trade only the patients who were likely experienced recurrent makes offer to redesign their efficient concentrating treatment in all at a patient population who needs it and leaving everybody else alone.

David Chang: We believe these key points are well aligned with abuse of FDA and other key stakeholders. We aim to validate the support for this trial. We have also continued to strengthen averaging, even if not in the spotlight or something that honors headlines, to ensure that we can deliver on our promises, such as the work done in our self-forged one facility in the East Bay, where we now manufacture all of our Carti investigational product. This significantly minimizes our reliance on contract manufacturers for the products and provides Algae with a critical strategic asset for manufacturing capacity to serve the market that we are addressing in our trials.

David Chang: We believe these key points are well aligned with the views of FDA and other key stakeholders. We aim to validate their support for this trial. We have also continued to strengthen Allogene, even if not in the spotlight or something that garners headlines, to ensure that we can deliver on our promises, such as the work done at our South Forge I facility in the East Bay, where we now manufacture all of our CAR T investigational products.

David Chang: We believe these key points are well aligned with the views of FDA and other key stakeholders. We aim to validate their support for this trial. We have also continued to strengthen Allogene, even if not in the spotlight or something that garners headlines, to ensure that we can deliver on our promises. Such as the work done at our South Forge I facility in the East Bay, where we now manufacture all of our CAR T investigational products.

Speaker Change: We believe these key points are well aligned with the abuse of FDA and other key stakeholders.

Speaker Change: We aim to validate their support for this trial.

Speaker Change: We have also continued to strength allergen, even if not in the spotlight or something that garners headlines to ensure that we can deliver on our promises such as the work done in our South Florida, one facility in the East Bay, where we now manufacture all of our car T investigational product.

Speaker Change: This significantly minimizes our reliance on contract manufacturers for our products and provides <unk> with a critical strategic asset for manufacturing capacity to serve the market that we're addressing in our trials.

David Chang: As the month continues, I am confident that this exceptional momentum we feel internally will become increasingly evident to the outside world.

David Chang: This significantly minimizes our reliance on contract manufacturers for the products and provides Allogene with a critical strategic asset, the manufacturing capacity to serve the market that we are addressing in our trial. As the months continue, I am confident that this exceptional momentum we feel internally will become increasingly evident to the outside world. I will now turn the call over to Zach to discuss the programs of most significant interest to investors.

Speaker Change: As the months continue.

Speaker Change: Content that this exceptional momentum, we feel internally will become increasingly evident to the outside world.

Speaker Change: I will now turn the call over to Zach to discuss the programs are not significant interest to investors.

Zachary Roberts: Thank you, David. As most of you know, our development focus in 2024 has been on our four core programs, Semicell for first-line consolidation in LBCL and relapse refractory CLL, Allo329 in autoimmune, and Allo316 in renal cell carcinoma. While our CLL and renal cell programs continue to move forward as planned, with a meaningful update from the RCC trial planned by year end, I will focus my remarks today on the two programs that we get most asked about: Demacel for first-line consolidation and Allo329 for autoimmune disease.

Zachary Roberts: Thank you, David. As most of you know, our development focus in 2024 has been on our four core programs, Semicell for first-line consolidation in LBCL and relapse refractory CLL, Allo329 in autoimmune, and Allo316 in renal cell carcinoma. While our CLL and renal cell programs continue to move forward as planned, with a meaningful update from the RCC trial planned by year-end, I will focus my remarks today on the two programs that we get asked about most, Demacel in first-line consolidation and Allo329 in autoimmune disease.

Zach: Thank you David as most of you know our development focus in 2024 has been on our four core programs <unk> for first line consolidation and L. Bcl and relapsed refractory CLO Allo 309 in autoimmune and allergy <unk> in renal cell carcinoma.

Zachary Roberts: Carl Carcinoma, while our CLL and renal cell programs continue to move forward as planned, with a meaningful update from the RCC trial planned by year end, I will focus my remarks today on the two programs that we get most asked about. I'll start with our lead program, Semisel and the Alpha-3 trial which we initiated in June. In just a few weeks following the investigational device exemption or IDE approval in mid-June, we've opened the first 10 community and academic cancer centers and have been successfully screening patients. The speed with which we've been able to bring community cancer centers into the trial, in particular, speaks volumes that we're going to focus on today.

Zach: While our CLO and renal cell programs continue to move forward as planned with a meaningful update from the RCC trial planned by year end I will focus my remarks today on the two programs that we get most asked about <unk>.

Speaker Change: <unk> in first line consolidation in our <unk> and autoimmune disease.

Zachary Roberts: I'll start with our lead program, SEMICEL, and the Alpha 3 trial, which we initiated in June. In just a few weeks following the Investigational Device Exemption, or IDE, approval in mid-June, we have opened the first 10 community and academic cancer centers and have been successfully screening patients. The speed with which we've been able to bring community cancer centers into the trial, in particular, speaks volumes for what this may mean commercially and reinforces our belief that an allogeneic CAR T option will be what opens the door to this modality for these centers where most patients are treated. First-line chemoimmunotherapy for LBCL has largely gone unchanged for a quarter century, and for good reason. ARCHOP and similar regimens work pretty well, with the majority of patients achieving cures with this easy-to-give, safe regimen.

Zach: I'll start with our lead program <unk> and the Alpha three trial, which we initiated in June.

Zach: And just a few weeks following the investigational device exemption or IDE approval in mid June we have opened the first 10 community and academic cancer centers and have been successfully screening patients.

Zachary Roberts: The speed with which we've been able to bring community cancer centers into the trial, in particular, speaks volumes for what this may mean commercially and reinforces our belief that an allogeneic CAR T option will be what opens the door to this modality for these centers where most patients are treated. First-line chemoimmunotherapy for LBCL has largely gone unchanged for a quarter century, and for good reason. ARCHOP and similar regimens work pretty well, with the majority of patients achieving cures with this easy-to-give, safe regimen.

Zach: Feed with which we've been able to bring community cancer centers into the trial in particular speaks volumes for what this may mean commercially and reinforces our belief that an allogeneic car T option will be what opens the door to this modality for these centers, where most patients are treated.

Zachary Roberts: This brings for what this may mean commercially and reinforces our belief that an Allogeneate CAR-T option will be what opens the door to this modality for these centers where most patients are treated. First-line chemoimmunotherapy for LBCL has largely gone unchanged for a quarter century and for good reason. Our chop and similar regimens work pretty well, with the majority of patients achieving cure with this easy to give, safe regimen. However, approximately one-third of patients with LBCL whose disease initially responds to our CHOP will experience relapse.

Speaker Change: First line chemo immunotherapy for <unk> has largely gone unchanged for a quarter century and for good reason R. Chop and similar regimens worked pretty well with the majority of patients achieving cure with this easy to give safe regimen.

Zachary Roberts: However, approximately one-third of patients with LBCL whose disease initially responds to RCHOP will experience relapse. Alpha-3 is a groundbreaking trial for two reasons. First, Alpha-3 is the first prospective trial that will utilize an ultrasensitive biomarker to inform physicians and patients whether the cancer is likely to cure by first-line R-CHOP or if the disease will likely recur and require second-line treatment or beyond. And second, Alpha-3 is the first trial to propose a treatment, namely a dose of semicells for remission consolidation, specifically for those patients who are likely to face a future

Speaker Change: Approximately one third of patients with <unk>, whose disease initially responds to R. Chop will experience relapse Alpha.

Zachary Roberts: Alpha-3 is a groundbreaking trial for two reasons. First, it is the first prospective trial that will utilize an ultra-sensitive biomarker to inform physicians and patients whether the cancer is likely cured by first line our chop or if the disease will likely recur and require second line treatment or beyond. And second, Alpha-3 is the first trial to propose a treatment, namely a dose of semisel for remission consolidation, specifically for those patients who are likely to face a future relapse.

Zach: Alpha three is a groundbreaking trial for two reasons first it is the first prospective trial that will utilize an ultra sensitive biomarker to inform physicians and patients whether it's a cancer is likely cured by first line R chop or if the disease will likely recur and require a second line treatment or beyond and second Alpha <unk> III.

Zach: Is the first trial to propose a treatment, namely a dose of MSL for emission consolidation specifically for those patients who are likely to face a future relapse.

Zachary Roberts: If positive, Alpha-3 could mark the beginning of a new era in LBCL treatment, potentially supplanting the current standard of care after frontline treatment, which has, for decades, been to watch and wait for the disease to relapse. We believe our partnership with Forsyte Diagnostics, who is developing a novel and potentially practice-changing tests for minimal residual disease, will change that. This investigational test, when administered following the completion of frontline treatment for LBCL, has the potential to offer a highly accurate prediction of future disease relapses. Alpha-3, therefore, offers something to all patients who screen. If the screening MRD test is positive, you are potentially eligible to receive a dose of CAR-T cells designed to eradicate the residual disease, hopefully attaining the cure, which remained elusive after our CHOP.

Zachary Roberts: If positive, Alpha 3 could mark the beginning of a new era in LBCL treatment, potentially supplanting the current standard of care after frontline treatment, which has for decades been to watch and wait for the disease to relapse. We believe our partnership with Foresight Diagnostics, which is developing a novel and potentially practice-changing test for minimal residual disease, will change that. This investigational test, when administered following the completion of frontline treatment for LBCL, has the potential to offer a highly accurate prediction of future disease relapses.

Zachary Roberts: If positive, Alpha 3 could mark the beginning of a new era in LBCL treatment, potentially supplanting the current standard of care after frontline treatment, which has for decades been to watch and wait for the disease to relapse. We believe our partnership with Foresight Diagnostics, who are developing a novel and potentially practice-changing test for minimal residual disease, will change that. This investigational test, when administered following the completion of frontline treatment for LBCL, has the potential to offer a highly accurate prediction of future disease relapses.

Speaker Change: If positive Alpha III could mark the beginning of a new era in <unk> Bcl treatment potentially supplanting. The current standard of care after frontline treatment, which has for decades been to watch and wait for the disease to relapse.

Zach: We believe our partnership with foresight diagnostics, who is developing a novel and potentially practice changing test for minimal residual disease will change that.

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

Zachary Roberts: Alpha 3, therefore, offers something to all patients who, If the screening MRD test is positive, you are potentially eligible to receive a dose of CAR T-cells designed to eradicate the residual disease, hopefully attaining the cure which remained elusive after R-CHOP. If the screening MRD test is negative, it could provide assurance that your disease has been fully cured. Peace of mind after a life-altering diagnosis and its treatment cannot be underestimated. Importantly, Alpha 3 builds on the growing understanding that administering CAR T therapies to patients with low disease burden can improve safety and efficacy outcomes. The industry has presented research that illustrates this point.

Zachary Roberts: Alpha 3, therefore, offers something to all patients who... If the screening MRD test is positive, you are potentially eligible to receive a dose of CAR T-cells designed to eradicate the residual disease, hopefully attaining the cure which remained elusive after R-CHOP. If the screening MRD test is negative, it could provide assurance that your disease has been fully cured. Peace of mind after a life-altering diagnosis and its treatment cannot be underestimated. Importantly, Alpha 3 builds on the growing understanding that administering CAR T therapies to patients with low disease burden can improve safety and efficacy outcomes. The industry has presented research that illustrates this point.

Zach: Alpha three therefore offer something to all patients who screen if the screening MRV test is positive you are potentially eligible to receive a dose of car T cells designed to eradicate residual disease, hopefully attaining the cure, which remained elusive after R. Chop.

Zachary Roberts: If the screening MRD test is negative, it could provide assurance that your disease has been fully cured.

Zach: If the screening MRV test is negative it could provide assurance that youre disease has been fully cured.

Zachary Roberts: Peace of mind after a life-altering diagnosis and its treatment cannot be underestimated. Importantly, Alpha-3 builds on the growing understanding that administering CAR-T therapies to patients with low disease burden can improve safety and efficacy outcomes. The industry has presented research that illustrates this point. Semicell's Phase-1 safety profile with low rates of CRS and ICANNs already permits its use in the outpatient setting in relapse for fractory patients, and may further improve in patients with no radiological evidence of disease.

Zach: Peace of mind after a life altering diagnosis and its treatment cannot be underestimated.

Zach: Importantly, alpha three builds on the growing understanding administering car T therapies to patients with low disease burden can improve safety and efficacy outcomes.

Speaker Change: The industry has presented research that illustrates this point <unk> phase one safety profile with low rates of Crs ni cans already permitted to use in the outpatient setting in relapsed refractory patients and may further improve in patients with no radiological evidence of disease can.

Zachary Roberts: SEMICEL's Phase 1 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. Combine this with the elimination of complex logistics that have hindered CAR T adoption, as well as the reliance on referrals, and we have, as David rightly noted, a clear momentum effect for the Alpha 3 trial with investigators.

Zach: Combine this with the elimination of complex logistics that have hindered carty adoption as well as the reliance on referrals and we have as David rightly noted a clear momentum effect for the Alpha three trial with investigators.

Zachary Roberts: As we have noted in previous calls, the outcome of this pivotal trial could allow Semicel to be embedded in the first-line setting where autologous therapies are far less feasible. Consolidating response with an MRD positive result post our job requires immediate and definitive action to prevent an impending relapse. Relapse is tend to occur quickly after completion of our job 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.

Zachary Roberts: As we have noted in previous calls, the outcome of this pivotal trial could allow semicell to be embedded in the first-line setting where autologous therapies are far less feasible. Consolidating response with an MRD-positive result post-R-CHOP requires immediate and definitive action to prevent an impending relapse. Relapses tend to occur 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. We bring to the table a truly differentiated CAR T offering that has the potential to break open an untapped market. Few can say that,

Speaker Change: As we have noted in previous calls the outcome of this pivotal trial could allow <unk> to be embedded in the first line setting where autologous therapies are far less feasible.

Speaker Change: Solidarity response without MRV positive result post R. Chop requires immediate and definitive action to prevent an impending relapse.

Speaker Change: Relapses tend to occur quickly after completion of R. 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 III.

Zachary Roberts: We bring to the table a truly differentiated CAR-T offering that has the potential to break open an untapped market. You can say that.

Speaker Change: We bring to the table a truly differentiated car T offering that has the potential to break open and untapped market you can say that.

Zachary Roberts: The first indication of how the trial is proceeding will be when we announce the selection of the lympho-depletion regimen. We will continue to the end of the trial. That announcement is expected in mid 2025. The next study milestones will come less than a year later. We expect a complete enrollment in the first half of 2026. The prognosis for patients who are MRD positive at the end of front line therapy is quite poor, so study events are expected to come in quickly. Therefore, we expect to perform efficacy analyses in 2026 as well. This will include an independent Data Safety Monitoring Board interim efficacy analysis in the first half of 2026.

Zachary 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 the end of the trial. That announcement is expected in mid-2025. The next study milestones will come less than a year later, and we expect to complete enrollment in the first half of 2026. The prognosis for patients who are MRD positive at the end of frontline therapy is quite poor, so study events are expected to come in quickly.

Speaker Change: 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.

Speaker Change: That announcement is expected in mid 2025.

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

Speaker Change: Prognosis for patients who are MRV positive at the end of frontline therapy is quite poor. So steady events are expected to come in quickly.

Zachary Roberts: Therefore, we expect to perform efficacy analyses in 2026 as well. 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 analysis at year-end 2026. If the trial is successful, we expect to follow these data readouts with a Biologics License Application submission in 2022. I'll now discuss ALLEL329.

Zachary Roberts: Therefore, we expect to perform efficacy analyses in 2026 as well. This will include an independent data safety monitoring board interim efficacy analysis in the first half of 2026 and data readout of the primary analysis at year-end 2026. If the trial is successful, we expect to follow these data readouts with a Biologics license application submission in 2022. I'll now discuss ALLO 329. Differentiation is critical across our core programs. We declared our move into the autoimmune space with the goal of resetting the immune system with a single infusion.

Speaker Change: Therefore, we expect to perform efficacy analysis in 2026 as well.

Speaker Change: 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 analysis yearend 2026.

Zachary Roberts: In the data readout of the primary analysis year end 2026.

Zachary Roberts: If the trial is successful, we expect to follow these data readouts with a Biologics License Application submission in 2027.

Speaker Change: If the trial is successful we expect to follow these data readouts with a biologics license application submission in 2027.

Zachary Roberts: I'll now discuss ALO-329. Differentiation is critical across our core programs. We declared our move into the autoimmune space with the goal of resetting the immune system with a single infusion. ALO-329, our next generation CD19 CD70 dual CAR, incorporates our dagger technology, CRISPR-based gene editing, and site-specific CAR-transducing integration, and is rationally designed to meet the unique needs of patients with autoimmune disease. Our dagger technology provides a potential path to reducing or eliminating lymphatic lesion, which we believe may create more development and commercial opportunities for ALO-329 in autoimmune indications. We are on track to file an IND in Q1 of 2025 and open the trial to enrollment by mid 2025.

Speaker Change: I'll now discuss allo 302 nine <unk>.

Zachary Roberts: Differentiation is critical across our core programs. We declared our move into the autoimmune space with the goal of resetting the immune system with a single infusion. Allo329, our next generation CD19-CD70 dual car, incorporates our Dagger technology, CRISPR-based gene editing, and site-specific car transgene integration, and is rationally designed to meet the unique needs of patients with autoimmune disease. Our Dagger technology provides a potential path to reducing or eliminating lymphodepletion, which we believe may create more development and commercial opportunities for Allo329 in autoimmune indications.

Speaker Change: Differentiation is critical across our core programs.

Speaker Change: We declared our move into the autoimmune space with the goal of resetting the immune system with a single infusion.

Zachary Roberts: Allo329, our next generation CD19-CD70 dual car, incorporates our Dagger technology, CRISPR-based gene editing, and site-specific car transgene integration, and is rationally designed to meet the unique needs of patients with autoimmune disease. Our Dagger technology provides a potential path to reducing or eliminating lymphodepletion, which we believe may create more development and commercial opportunities for Allo329 in autoimmune indications.

Speaker Change: Our <unk> our next generation <unk> 19, CD 70 dual car incorporates our <unk> technology CRISPR based gene editing and site specific car Trans gene integration and as rationally designed to meet the unique needs of patients with autoimmune disease.

Speaker Change: <unk> technology provides a potential path to reducing or eliminating them for depletion, which we believe may create more development and commercial opportunities for allo 329, and autoimmune indications.

Zachary Roberts: We are on track to file an IND in Q1 of 2025 and open the trial to enrollment by mid-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 we also know the importance of differentiation, and the path we are taking provides us with the luxury of time to define the best approach while leveraging proof of concept data from other trials to consider other indications with unmet needs.

Speaker Change: We are on track to file an IND in Q1 of 2025 and open the trial to enrollment by mid 2025.

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

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

Zachary Roberts: We recognize that highest clinical proof of concept is Enlupus, but we also know the importance of differentiation. In the path we are taking provides us a luxury of time to define the best approach while leveraging proof of concept data from other trials to consider other indications with unmet needs.

Speaker Change: We recognize that highest clinical proof of concept is in lupus, but we also know the importance of differentiation and the path. We are taking provides us the luxury of time to define the best approach, while leveraging proof of concept data from other trials to consider other indications with unmet need.

Zachary Roberts: We expect to provide more detail on our development plan by the end of the year and appreciate the feedback many of you have provided as we chart this course.

Zachary Roberts: We expect to provide more detail on our development plan by the end of the year and appreciate the feedback many of you have provided as we chart this. I'll now turn the call over to Geoff to review our latest financial... Thank you, Zach.

Speaker Change: We expect to provide more detail on our development plan by the end of the year and appreciate the feedback. Many of you have provided as we chart. This course.

Jeff Parker: I'll now turn the call over to Jeff to review our latest financials. Thank you, Zach. Before I dive into the financials, I'd like to express my appreciation to the investors who continue to demonstrate their support for our work. I know this market makes it a challenge, but I assure you, we do not take that support for granted. I cannot agree more with David and Zach. The momentum we have at ALO-GEN is palpable, and we believe it will soon be equally evident to the market. Allogene is in a unique position. We control the only clinically validated Allogeneity CD-19 CARTI product positioned to transform how and where CARTIs are used in HEME malignancies.

Speaker Change: I'll now turn the call over to Jeff to review our latest financials.

Geoffrey Parker: Thank you, Zach. Before I dive into the financials, I'd like to express my appreciation to the investors who continue to demonstrate their support for our work. I know this market makes it a challenge, but I assure you, we do not take that support for granted.

Jeff: Thank you Zack before I dive into the financials I'd like to express my appreciation to the investors who continue to demonstrate their support for our work.

Jeff: I know this market makes it a challenge, but I assure you we do not take that support for granted.

Geoffrey Parker: The momentum we have at Allogene is palpable, and we believe it will soon be equally evident to the market. Allogene is in a unique position. We control the only clinically validated allogeneic CD19 CAR-T product positioned to transform how and where CAR-Ts are used in heme malignancy. The recognition of this will only grow over the next 6 to 12 months as the Alpha 3 program is de-risked. Let me now turn to our financial highlights.

Geoffrey Parker: The momentum we have at Allogene is palpable, and we believe it will soon be equally evident to the market. Allogene is in a unique position. We control the only clinically validated allogeneic CD19 CAR T product positioned to transform how and where CAR Ts are used in heme malignancy. The recognition of this will only grow over the next 6 to 12 months as the Alpha 3 program is de-risked. Let me now turn to our financial highlights.

Jeff: I could not agree more with David and Zach the momentum we have at Allergan is palpable and we believe it will soon be equally evident to the market.

Speaker Change: Allergy is in a unique position 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. The recognition for this will only grow over the next six to 12 months as the Alpha three program is DRAM.

Jeff Parker: The recognition for this will only grow over the next six to 12 months as the Alpha 3 program is de-risked.

Jeff Parker: Let me now turn to our financial highlights. Our cash balance as of the end of Q2 2024 was $444.6 million in cash, cash equivalents, and investments, and we reiterate that our cash runway extends into the second half of 2026. Q2 2024 research and development expenses were $50.4 million, which includes $5.3 million in expenses associated with non-cash stock-based compensation. General and administrative expenses in Q2 were $16.1 million, which includes $8.2 million of non-cash stock-based compensation expense.

Geoffrey Parker: Our cash balance as of the end of Q2 2024 was $444.6 million in cash, cash equivalents, and investment. And we reiterate that our cash runway extends into the second half of 2026. Q2 2024 research and development expenses were $50.4 million, which included $5.3 million in expenses associated with non-cash stock-based compensation. General and administrative expenses in Q2 were $16.1 million, which included $8.2 million of non-cash, stock-based compensation expense. For Q2 2024, our net loss was $66.4 million, or $0.35 per share, including non-cash stock-based compensation expense of $13.6 million and $5 million in non-cash impairment of long-lived asset expense.

Geoffrey Parker: Our cash balance as of the end of Q2 2024 was $444.6 million in cash, cash equivalents, and investment. And we reiterate that our cash runway extends into the second half of 2026. Q2 2024 research and development expenses were $50.4 million, which included $5.3 million in expenses associated with non-cash stock-based compensation. General and administrative expenses in Q2 were $16.1 million, which included $8.2 million of non-cash, stock-based compensation expenses. For Q2 2024, our net loss was $66.4 million, or $0.35 per share, including non-cash stock-based compensation expense of $13.6 million and $5 million in non-cash impairment of long-lived asset expense.

Speaker Change: <unk>.

Speaker Change: Let me now turn to our financial highlights.

Speaker Change: Our cash balance as of the end of Q2, 2024 was $444 $6 million in cash cash equivalents and investments and we reiterate that our cash runway extends into the second half of 2026.

Speaker Change: Q2, 2020 for our research and development expenses were $54 million.

Speaker Change: Which includes $5 3 million and expenses associated with noncash stock based compensation.

Speaker Change: General and administrative expenses in Q2, or $16 1 million, which includes $8 2 million of <unk>.

Speaker Change: Noncash stock based compensation expense.

Jeff Parker: For Q2 2024, our net loss was $66.4 million, or $35 per share, including non-cash stock-based compensation expense of $13.6 million and $5 million in non-cash impairment of long-lived asset expense. For Q2 2024, we continue to expect a cash burn of approximately $200 million. 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.

Speaker Change: For Q2, 2024, our net loss was $66 4 million or.

Speaker Change: Or <unk> 35 per share, including noncash stock based compensation expense of $13 $6 million and $5 million in noncash impairment of long lived asset expense.

Geoffrey Parker: For 2024, we continue to expect a cash burn of approximately $200 million. 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.

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

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

Speaker Change: Which includes estimated noncash stock based compensation expense of approximately $60 million.

Jeff Parker: This guidance excludes any impact from potential business development activities.

Speaker Change: This guidance excludes any impact from potential business development activities.

Operator: We'll now open the call for questions. Thank you. Ladies and gentlemen, to ask the question, please press star 111 on your telephone, and then wait to hear your name announced. To withdraw your question, please press star 111 again. We ask that you limit yourself to one question per caller.

Operator: We'll now open the call for questions. Thank you.

Speaker Change: We'll now open the call for questions.

Operator: Ladies and gentlemen, 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. We ask that you limit yourself to one question per call. Please stand by while we compile the Q&A list. Our first question comes from the line of Salveen Richter with Goldman Sachs. Your line is open.

Operator: Ladies and gentlemen, to ask a question, please press star 11 on your telephone and then wait to hear your name announced. To withdraw your question, please press star 11 again. We ask that you limit yourself to one question per call. Please stand by while we compile the Q&A list. Our first question comes from the line of Salveen Richter with Goldman Sachs. Your line is open.

Speaker Change: Thank you.

Speaker Change: Ladies and gentlemen to ask a question. Please press star one on your telephone and then wait to hear your name announced.

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

Speaker Change: We ask that you limit yourself to one question per caller.

Operator: Please stand by while we come out with Q&A roster.

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

Salveen Richter: Our first question comes from the line of salving risk with Goldman Sachs. Yaline is open.

Speaker Change: Our first question comes from the line of Salve, Richard with Goldman Sachs. Your line is open.

Zachary Roberts: Hi, this is Lydia on preselving. Thanks so much for taking the question. Just on submissile in the frontline consolidation setting, could you speak to any gating factors that might prevent a patient, an MRD positive patient from opting for submissile, and are there any clinical preferences that you're hearing from KOLs, or a setting where this might not be recommended?

Lydia: Hi, this is Lydia on behalf of Salveen. Thanks so much for taking our question. Just on Semicell in the frontline consolidation setting, could you speak to any gating factors that might prevent a patient, an MRD-positive patient, from opting for Semicell? And are there any clinical preferences that you're hearing from KOLs or a setting where this might not be recommended?

Zachary Roberts: Thank you so much.

Speaker Change: Hi, This is <unk> on for soybean. Thanks, so much for taking our question.

Zachary Roberts: Thank you so much.

Speaker Change: Just one for Michelle in the frontline consolidations Robin could you speak to any gating factors that might prevent a patient in MRV participation from opting for some Michelle are there any clinical preferences, what youre hearing from kols or setting where this might not be recommended thank you. So much.

Zachary Roberts: Thank you so much.

Zachary Roberts: Hi, Lydia. This is Zach. Thanks for the question. So if I understood it correctly, you're asking about what a patient may decide if they come back and already bothered whether alpha-3 is the right study for them or not. So right now, there are no real alternatives for patients who come back MRD positive. There are no approved second-line therapies for patients who are in remission, even if they have an MRD-positive result. The only option that they currently have would be in the context of a clinical trial, and the only clinical trial that currently is open for patients who have an MRD positive result at the end of therapy is Alpha-3.

Operator: Hi Lydia, this is Zach. Thanks for the question. So if I understand you correctly, you're asking about what a patient may decide if they come back MRT-positive, whether Alpha-3 is the right study for them or not. So right now, there are no real alternatives for patients who come back MRD-positive. There are no approved second-line therapies for patients who are in remission, even if they have an MRD-positive result. The only option that they currently have would be in the context of a clinical trial, and the only trial that is currently open for patients who have an MRD-positive result at the end of therapy is alpha-3. So it should be a fairly straightforward decision for patients.

Zachary Roberts: Hi Lydia, this is Zach. Thanks for the question. So if I understand you correctly, you're asking about what a patient may decide if they come back MRT-positive, whether Alpha-3 is the right study for them or not. So, right now, there aren't any. Real alternatives for patients who come back MRD-positive. However, there are no approved second-line therapies for patients who are in remission, even if they have an MRD-positive result. The only option that they currently have would be in the context of a clinical trial, and the only clinical trial that is currently open for patients who have an MRD-positive result at the end of therapy is alpha-3. So it should be a fairly straightforward decision for patients.

Speaker Change: Hi, <unk>. Thanks for the question. So if I understood. It correctly you are asking about what.

Speaker Change: What does what a patient may decide if they come back and Marty positive weather Alpha three at the right study for them or not.

Speaker Change: So.

Speaker Change: Right now there are no.

Speaker Change: Real alternatives for patients who come back and Mardi positive there are no approved.

Speaker Change: Line therapies for patients who are in remission, even if they have an MRV positive result, the only option that they currently have would be in the context of a clinical trial and the only clinical trial that currently is spoken for patients who have an <unk> positive results at the end of therapy as alpha III. So it should be a fairly stray.

Zachary Roberts: So it should be a fairly straightforward decision for patients.

Speaker Change: Forward decision for patients.

Zachary Roberts: Thank you.

Operator: Please stand by for our next question.

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

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

Brian Chinn: Our next question comes from the line of branching with JP Morgan. Your line is open. Hey guys, thanks for taking our questions today. Maybe just two on Alpha 3. Can you provide some early initial metric on the screen outrage on MRD positivity? Is it in line with our expectation? And then on the supply side, I just want to follow up on your remarks related to the Salesforce 1 facility. Can you confirm whether the supply now is actively coming from the Salesforce 1 for the Alpha 3? And then I have one quick follow-up.

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

Speaker Change: Our next question comes from the line of Brian Cheng with J P. Morgan Your line is open.

David Chang: Hey guys, thanks for taking our questions today. Maybe just two on Alpha 3. Can you provide some early initial metric on the screen-out rate for MRD positivity? Is it in line with our expectation? And then on the supply side, I just want to follow up on your remarks related to the CellForge1 facility. Can you confirm whether the supply is now actively coming from CellForge1 for the Alpha 3? And then I have one quick follow-up. Thank you.

Brian Ching: Hey, guys. Thanks for taking our questions today. Maybe just two on Alpha 3.

Brian Cheng: Hey, guys. Thanks for taking our question today.

Brian Cheng: Just two on Alpha three can you provide some early initial metric on that screen out rate on MRI <unk> positivity.

David Chang: Can you provide some early initial metrics on the screen-out rate for MRD positivity? Is it in line with our expectation? And then on the supply side, I just want to follow up on your remarks related to the Cell Force 1 facility. Can you confirm whether the supply is now actively coming from Cell Force 1 for Alpha 3? And then we'll have one quick follow-up.

Speaker Change: In line with our expectation.

Speaker Change: Then on the supply side.

Speaker Change: I just wanted to follow up on your remarks related to the southwest one facility.

Speaker Change: Can you confirm whether the supply now is actively coming from.

Speaker Change: The southwest one for the Alpha three and then one quick follow up thank you.

Brian Chinn: Thank you.

David Chang: Hey Brian, this is David Chang. I'll take both of those questions. With respect to the early metrics that we are following for the Alpha 3 study. I mean, you know, we started the study, and as we have made a comment in the pre-pair statement, you know, there are 10 active sites that are sending patients for screening and enrollment. The metrics that we follow, I mean, certainly in their internal ones, but now we consider that these are very standard metrics that any clinical operations team would follow. So there's not anything unique.

David Chang: Hey, Brian. This is David Chang.

Speaker Change: Hey, Brian This is David Chang I'll take both of those questions.

David Chang: I'll take both of those questions. With respect to the early metrics that we are following for the Alpha 3 study, I mean, you know, we started the study, and as we have made a comment in the prepared statement, you know, there are 10 active sites that are sending patients for screening and enrollment. The metrics that we follow, I mean, certainly, there are internal ones, but I would consider that these are very standard metrics that any clinical operations team would follow.

Speaker Change: With respect to the early metrics that we are following put out the three study.

Speaker Change: We started the study and as we have made a comment in the prepared statement.

Speaker Change: Our 10 active sites.

Speaker Change: Sending patients for screening and enrolment.

Speaker Change: The metrics that we follow I mean, certainly there are internal ones, but I would consider that piece out there is standard metrics that any clinical operations team would follow so there's not anything unique.

David Chang: So there's not anything unique. As the study progresses a little bit more, we will be able to provide some information in regards to, you know, the MRD positive rate and things like that, but right now, it's too early to comment on that. The second one, the response is pretty easy. With the ongoing studies, especially the Alpha 3 study, which is the study that you are referring to, yes, the clinical material for the Alpha 3 is coming from the CF1-manufactured Somersault.

David Chang: As the study progresses a little bit more, you know, we will be able to provide some information of, you know, regards to, you know, the MRD positive rate and things like that, but right now it's purely to comment on that. The second one, the response is pretty easy with the ongoing studies, especially the Alpha 3 study, which is what the study that you are referring to. Yes, the clinical material for the Alpha 3 is coming from the CFL manufactured somehow. Okay.

Speaker Change: The study progress a little bit more we will provide you able to provide some information.

Speaker Change: With regards to <unk>.

Speaker Change: I'm already positive rate and things like that but right now it's too early to comment on that.

David Chang: As the study progresses a little bit more, we will be able to provide some information in regards to, you know, the MRD positive rate and things like that, but right now, it's too early to comment on that. The second one: the response is pretty easy. With the ongoing studies, especially the Alpha 3 study, which is what the study that you are referring to, yes, the clinical material for the Alpha 3 study is coming from the CF1-manufactured semicell.

Speaker Change: The second one the response is pretty easy.

Speaker Change: With the ongoing studies, especially.

Speaker Change: Copper III study, which is what decided that youre, referring to yes, the clinical material put alpha three is coming from the CF flatten manufactured solar cell.

David Chang: Okay, and then maybe just I'm curious about your thoughts around the, because we saw a relapse case with an autologous CD19 CAR-T program out of ULAR back in June. I'm just curious what your thoughts are on that data set and, you know, and does that have any impact on how you think about, you know, your dosing or lymphodepletion regimen for 329? Thanks for taking our questions.

David Chang: Okay, and then maybe just curious about your thoughts on this, because we saw a relapse case with an autologous CD19 CAR-T program out of ULAR back in June. Just curious what your thoughts are on that data set, and does that have any impact on how you think about, you know, your dosing or lymphodepletion regimen for 329? Thanks for taking our question.

David Chang: And then maybe just curious on your thoughts around the, because we saw recently a relapse case with an autologous CD19 CAR T program out of ULAR back in June. Just curious what your thoughts are on that data set. And do you have any, and does that have any impact on how you think about, you know, your dosing or lympho depletion regimen for three to nine. Thanks for taking our question. Yeah, so that's sort of an added question. I think, you know, that is referring to the autologous CD19 CAR T being studied autoimmune indications. You know, the way we view is that, you know, still there is a lot going on with the signal finding and, you know, the proof concept data being generated.

Speaker Change: Okay, and then maybe just curious on your thoughts around that.

Speaker Change: We thought recently relaxed case.

Speaker Change: With an autologous CD 19 car T program out of your life back in June.

Speaker Change: Just curious what your thoughts are on that data set and do you have any does that have any impact on how you think about dosing our lymphoid depletion regimen for three to nine thanks for taking our questions.

David Chang: Yeah, so that's sort of an added question. I think, you know, that is referring to the autologous CD19 CAR-T being studied in autoimmune indications. The way we view it is that, you know, still there's a lot going on with the signal finding and, you know, the proof of concept data being generated. As that happens, you know, there will be some, you know, variability.

Speaker Change: Yes, so thats sort of an added question I think that is referring to the autologous CD 19 car T being studied in auto immune indications.

Speaker Change: The way we view is that.

Speaker Change: There is a lot going on with a signal finding and the proof of concept data being generated.

David Chang: As that happens, you know, there will be some variability. I don't think, you know, the recent findings that, as reported at ULAR, it doesn't really change any assumptions around what the CAR T therapy can do in the autoimmune indications. You know, what we are seeing, you know, fundamentally is very different than all out of treatment that has gone forward in the autoimmune indication. You know, specifically the, you know, potential of being able to provide long-term remission after a single infusion; that is very attractive. You know, the duration of long-term remission, I think that's what's coming into question and what is, you know, the length of remission that would really, you know, make us to get excited about.

Speaker Change: That has seen that there will be some.

David Chang: I don't think, you know, the recent findings as reported at ULA don't really change any assumptions around what the CAR-T therapy can do in the autoimmune indications. What we are seeing, you know, fundamentally is very different from all other treatment that has gone forward in the autoimmune indications. You know, specifically the potential of being able to provide long-term remission after a single infusion is very attractive. But, the duration of long-term remission, I think that's what's coming into question, and what is the length of remission that would really make us get excited about.

Speaker Change: Barry ability.

Speaker Change: I don't think the recent findings said as reported July it doesn't really change any assumptions around what the.

David Chang: I don't think, you know, the recent findings as reported at ULA don't really change any assumptions around what CAR-T therapy can do in autoimmune indications. What we are seeing, you know, fundamentally is very different from all other treatment that has gone forward in autoimmune indications, specifically the potential of being able to provide long-term remission after a single infusion. That is very attractive.

Speaker Change: Car T therapy can do into autoimmune indications.

Speaker Change: What we are seeing fundamentally is very different than all other treatment that has gone forward into autoimmune indication specifically.

Speaker Change: The potential of being able to provide long term remission. After a single infusion that is very attractive.

David Chang: You know, the duration of long-term remission, I think that's what's coming into question, and what is, you know, the length of remission that would really make us get excited about. I think that, you know, is something that we are following closely, but most of the patients who have been treated with the autologous CD19 CAR-T and also with some other, you know, BCMA CAR-T, what we are seeing is that the durability of response is very good, lasting a year or longer and sometimes ongoing response as the last data cuts.

Speaker Change: The duration of long term remission, I think thats whats coming into question and what is.

Speaker Change: The length, we mentioned that would really.

Speaker Change: May cause us to get excited about I think that is something that we are following closely but most of the patients who have been treated with Dell autologous CD 19 car T and also with some other <unk> car T. What we are seeing is that the durability of response is.

David Chang: I think that, you know, is something that we are following closely, but in most of the patients who have been treated with the autologous CD19 CAR-T and also with some other, you know, allogeneic CAR-T, what we are seeing is that the durability of response is very good, lasting a year or longer and sometimes ongoing response as the last data cuts. So it really doesn't change any of the assumptions that we are making with our Allo3 to 9, which as an allogeneic CAR-T provides a lot more benefit that will be important as we think about the autoimmune indication.

David Chang: I think that, you know, is something that we are following closely, but most of the patients who have been treated with the autologous CD19 CAR T. And also with some of their, you know, BCMA CAR T, what we are seeing is that the durability of response is very good, lasting a year longer and sometimes ongoing response as the last data, you know, cuts. So it really doesn't change any of the assumptions that we are making with our allotry tonight, which, as an allotry, CAR T provides a lot more benefit that will be important as we think about the autoimmune indications.

David Chang: So it really doesn't change any of the assumptions that we are making with our Allo-3 to 9, which as an allogeneic CAR-T provides a lot more benefit that will be important as we think about the autoimmune indications.

Speaker Change: Very good lasting longer and sometimes the ongoing response as to the last data cut so it really doesn't change any of the assumptions that we are making with our luxury to nine which as an allogeneic car T provides a lot more benefit that will be important.

Speaker Change: As we think about the order you mean indications.

Operator: Thank you.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Michael Yee with Jeffries. Your line is open.

Michael Yee: Please stand by for our next question. Our next question comes from the line of Michael Yee with Geoffrey; Cielan is open. Hi, thanks for taking our questions.

Speaker Change: Thank you ladies stand back for our next question.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Michael Yee with Jeffrey. The line is open.

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

Jenna Li: Hi, thanks for taking our questions. This is Jenna Li for Mike at Jeffries, and congrats on getting the Alpha 3 trial started. Would you give a comment on the pace of ramping up for more sites, particularly thinking about leveraging the old sites that you had for the Alpha study and branching out to newer sites and balancing academic versus community and where the less severe frontline patients may be based? Thank you.

Jen Ali: Hi, thanks for taking our questions. This is Jen Ali for Mike at Jefferies, and congrats on getting the Alpha 3 trial started. Would you be able to comment on the pace of ramping up for more sites, particularly thinking about leveraging the old sites that you had for the Alpha study and branching out to newer sites and balancing academic versus community and where the less severe frontline patients may be based? Thank you.

Zachary Roberts: This is Genlea for Mike at Geoffrey, and congrats on getting the Alpha 3 trial started. Would you give a comment on the pace of ramp up for more sites, particular thinking about leveraging the old sites that you have for Alpha 3. This is a great study and branching out to newer sites and balancing academic versus community and where the less severe frontline patients may be based on. Thank you.

Michael Yee: Hi, Thanks for taking our questions. This is Jon on for.

Mike Jeffries: Mike Jeffries.

Jon: Congrats on getting the Alpha trial started.

Speaker Change: You have a comment.

Speaker Change: The pace of ramp up for more sites particular thinking about.

Speaker Change: Leveraging the Oh sorry.

Speaker Change: So you had for Alpha study and branching out from your sights on balancing academic versus community and where.

Speaker Change: Yeah.

Speaker Change: Less of the frontline patients may be may start thank you.

Zachary Roberts: Hi, this is Zach. So great question. And so the approach that we are taking is, I would say, both similar and distinct from what we've taken in the later line studies that we've had ongoing for a few years at Allogene. As you rightly point out in your question, the target population that we are pursuing in Alpha 3 for the most part are treated in the community. There are some patients who do get treated at large academic centers, either from the outset or through referral. But up to about 80% of patients with frontline are newly diagnosed, LDCL are treated in the community.

Zachary Roberts: Hi, this is Zach. So, a great question. And so the approach that we are taking is, I would say, both similar and distinct from what we've taken in the later line studies that we've had ongoing for a few years at Allogene. As you rightly point out in your question, the target population that we are pursuing in Alpha 3, for the most part, is treated in the community. There are some patients who do get treated at large academic centers, either from the outset or through referral, but up to about 80% of patients with frontline, newly diagnosed LBCL are treated in the community.

Speaker Change: Yeah.

A: Hi, this is a.

Speaker Change: Great question.

Speaker Change: And so the approach that we're taking is I would say both.

Speaker Change: Similar and distinct from what we've taken in the later line studies that we've had ongoing for a few years of allergy as you.

Speaker Change: You point out in your question the target population that we are pursuing an alpha three.

Speaker Change: For the most part are treated in the community. There are some patients who do get treated at large academic centers either from the outset, our through referral, but up to about 80% of patients with frontline or newly diagnosed <unk> are treated in the community that fact alone is really guided our decision making.

Zachary Roberts: That fact alone has really guided our decision making around site selection. And so, as we mentioned in the prepare remarks and is reflected on clinical trial.gov, the early wave of studies that have activated sites that have activated in this study have indeed been community centers, which are the common centers for frontline care. That said, the large academic referral centers are always going to have a role to play in clinical trial execution. And so, as those that list grows on ClinicalTrials.gov, you'll see some familiar faces with partners that we have had for a long time. And also say that we've expanded our reach into some academic centers that have not opened up study before.

Zachary Roberts: That fact alone has really guided our decision making around site selection. And so, as we mentioned in the prepared remarks and as is reflected on clinicaltrials.gov, the early wave of studies that have activated sites that have been activated in this study have indeed been community centers, which are the common centers for frontline care. That said, the large academic referral centers are always going to have a role to play in clinical trial execution. And so as that list grows on clinicaltrials.gov, you'll see some familiar faces with partners that we have had for a long time.

Zachary Roberts: That fact alone has really guided our decision making around site selection. And so, as we mentioned in the prepared remarks, and as reflected on clinicaltrials.gov, the early wave of studies that have activated sites that have been activated in this study have indeed been community centers, which are the common centers for frontline care. That said, the large academic referral centers are always going to have a role to play in clinical trial execution. And so, as that list grows on clinicaltrials.gov, you'll see some familiar faces with partners that we have had for a long time.

Speaker Change: Round site selection and so as we mentioned in the prepared remarks and as reflected on clinical trials Dot Gov.

Speaker Change: Early wave of studies that are activating sites that are activated in this study have indeed been community centers, which are the common centers for our frontline care.

Speaker Change: That said.

Speaker Change: The large academic referral centers are always going to have a role to play in.

Zachary Roberts: But I'll also say that we've expanded our reach into some academic centers that have not opened up studies before. So, we are actually pretty excited about the breadth and the variety in the types of sites, both old and new, community and academic, as we get this study up and running.

Speaker Change: In clinical trial execution and.

Speaker Change: So as those that list grows on clinical trials Gov Youll see some familiar faces with partners that we've had for a long time, but I also say that we've expanded our reach into some academic centers.

Zachary Roberts: I'll also say that we've expanded our reach into some academic centers that have not opened up studies before. So we're actually pretty excited about the breadth and the variety and the types of sites, both old and new, community and academic, as we get this study up and running.

Speaker Change: Not opened up studies before so we're actually pretty excited about the breadth and the variation in the types of sites, both old and new community and academic is we're getting the study up and running.

Zachary Roberts: So we are actually pretty excited about the breadth and the variation in the types of sites, both old and new community and academic, as we're getting this study up and running.

Tyler Van Buren: Thank you. Please stand by for our next question. Next question comes from the line of Tyler Van Buren with TV Cohen; you're on, it's open.

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

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

Speaker Change: Thank you ladies.

Speaker Change: Please standby for our next question.

Tyler Van Buren: Hey Tyler, Zach. Thanks for the question. So, you know, as we mentioned, and we've modeled out, and we've discussed in this venue before, we've modeled out what the expected time to event is, EFS, in this case, for patients who are in the observation arm. And it's quite short.

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

Zachary Roberts: Hey guys, good evening. Congratulations on all the progress. So if enrollment for alpha three is expected to complete during the first half of 2026, you will elaborate on what the interim EFS analysis during the first half of 2026 is expected to look like in what its specific purposes and why you need it just ahead of the final EFS analysis.

Speaker Change: Hey, guys. Good evening, congratulations on all the progress.

Speaker Change: So if enrollment for alpha three is expected to complete during the first half of 2026 can you elaborate on what the interim analysis. During the first half of 2026 and is expected to look like and what.

Speaker Change: Specific purposes, and why you need it just ahead of the final OS analysis by year end.

Zachary Roberts: Hey Tyler, Zach, thanks for the question. So, you know, as we mentioned, we've modeled out and we've discussed on in this venue before we've modeled out what the expected time to event is EFS in this case for patients who are in the observation arm, and it's quite short. I mean, the prognosis of these patients with MRD positive disease at the end of our CHOP is poor, and the time to progression is measured in weeks to months. So that's given us the opportunity to perform this interim analysis, and we haven't gone into details around what the volume or the percentage of the data that we will be examining of that interim analysis is.

Zachary Roberts: I mean, the prognosis of these patients with MRD-positive disease at the end of our CHOP is poor, and the time to progression is measured in weeks to months. So, that's given us the opportunity to perform this interim analysis, and, you know, we haven't gone into details around what the volume or the percentage of the data that we will be examining at that interim analysis is, but it will allow us to potentially initiate conversations with FDA.

Tyler Van Buren: Hey Tyler, Zach. Thanks for the question. So, you know, as we mentioned, and we've discussed this venue before, we modeled out what the expected time to event is, EFS, in this case, for patients who are in the observation arm, and it's quite short. I mean, the prognosis for these patients with MRD-positive disease at the end of our CHOP is poor, and the time to progression is measured in weeks to months.

Tyler: Hey, Tyler Tac.

Speaker Change: For the question so.

Speaker Change: As we mentioned.

Tyler Tac: We've modeled out and we've discussed in this venue before we've modeled out what the what the expected time to event is <unk> in this case for patients.

Speaker Change: Who are in the observation arm and it's quite short I mean, the prognosis of these patients with <unk> positive disease at the end of R. Chop is poor and the time to progression as measured in weeks to months.

Tyler Van Buren: So, that's given us the opportunity to perform this interim analysis, and we haven't gone into details around what the volume or the percentage of the data that we will be examining at that interim analysis is, but it will allow us to potentially initiate conversations with FDA. It will also allow us to get a sense of what the potential market penetration could be, so there are a lot of significant practical benefits to having an early formal look at that data that will certainly guide us in the direction of what we expect for the primary as well. So, all those balls will be able to begin rolling in the first half of 2026. That's our vision.

Speaker Change: So that's given us the opportunity to perform this this interim analysis and we haven't gone into details around what the.

Speaker Change: The volume or the percentage of the data that we will be examining a better interim analysis is.

Zachary Roberts: But it will allow us to potentially initiate conversations with the FDA. It will also allow us to get a sense of, you know, what the potential market penetration could be. So there are a lot of quite significant practical benefits to having an early formal look at that data that will certainly guide us in the direction of what we expect for the primary as well.

Speaker Change: But it will allow us to potentially initiate conversations with FDA and will also allow us to get a sense of what the potential market penetration could be so there are a lot of quite significant practical benefits to having an early form of look at that data that we'll certainly guide us in the direction of what we.

Zachary Roberts: It will also allow us to get a sense of, you know, what the potential market penetration could be. So, there are a lot of significant practical benefits to having an early formal look at that data that will certainly guide us in the direction of what we expect for the primary as well. So, all those balls will be able to begin rolling in the first half of 2026. That's our vision.

Zachary Roberts: So all those balls will be able to begin rolling in the first half of 2026. That's our vision. Thank you.

Speaker Change: For the primary as well so all of those balls will be we'll be able to begin rolling in the first half of 2026, that's our vision.

Operator: Please stand by for our next question.

Zachary Roberts: Thank you. Please stand by for our next question. Our next question comes from the line of Jack Allen with Bayer. Your line is open.

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

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

Jack Allen: Our next question comes from the line of Jack Allen with Bear. Your line is open. Great. Thanks so much for taking the questions, and congratulations on the progress made over the quarter. I just wanted to ask a couple here.

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

Jack Allen: Great, thanks so much for taking the questions and congratulations on the progress made over the quarter. I just wanted to ask a couple here, the first on the manufacturing process update. It sounds like all the product is now coming from CellForge1. I just wanted to ask if you have any sense of any differences in potency as it relates to CellForge1 manufactured products as compared to CMO products. Were there any changes in the process?

Jack Allen: Great. Thanks so much for taking the questions and congratulations on the progress made over the quarter. I just wanted to ask a couple here.

Jack Allen: Great. Thanks, so much for taking the questions and congratulations on the progress made over the quarter.

Zachary Roberts: The first is on the manufacturing process update. It sounds like all the product is now coming from CellForge1. I just wanted to ask if you have any sense for any differences in potency as it relates to CellForge1 manufactured products as compared to CMO products. Were there any changes in the process there? Is it still the alloy process that you're utilizing at both centers? And then, really briefly, on CLL, I was hoping you could provide some context as to what we should look for in early 25. We'd love to hear about the size and breadth of that data set that we should expect in early.

Jack Allen: The first, which is on the manufacturing process update. It sounds like all the product is now coming from self-words one. I just wanted to ask if you have any sense for any differences in potent. So you as it relates to self-words one manufactured products as compared to CMO products. Were there any changes in the process there? Is it still the alloy process that you are utilizing at both centers?

Jack Allen: I just wanted to ask a couple of here the first of which is on the manufacturing process update it sounds like all the product is now coming from software is one I just wanted to ask if you have any sense for any differences in potency as it relates to sell fourth one manufactured products as compared to CMO products.

Operator: Hello, and thank you for standing by. Welcome to Allogene Therapeutics' second quarter, 2024 conference call. At this time, all participants are going to listen only mode.

Operator: After the speaker's presentation, there will be a question and answer session. To ask the question during this session, you will need to press star 11 on your telephone. You will then hear automatic message advising your hand is raised. To withdraw your question, please press star 11 again.

Speaker Change: Were there any changes in the process there or is it still the alloy process that you I think that both centers and then really briefly on <unk> I was hoping you could provide some context as to what we showed before in early 'twenty five.

Jack Allen: Is it still the alloy process that you're utilizing at both centers? And then, really briefly, on CLL, I was hoping you could provide some context as to what we should look for in early 25. I would love to hear about the size and breadth of that data set that we should expect in early.

Jack Allen: And then really briefly on CLL, I was hoping you could provide some context as to what we should look for in early 25.

Zachary Roberts: We'd love to hear about the size and breadth of that data set that we should expect in the early next year.

Speaker Change: But love to hear about the size and breadth of that data set that we should expect in early next year.

David Chang: Hi Jack. Thanks for the questions. Let me take the manufacturing questions, and I will defer the CLR question to Zach. In terms of manufacturing, we have successfully manufactured all the products that we are currently investigating in the clinics at CF1. With respect to the details of how we are characterizing, we have a very high standard for characterizing the products, and that includes potency. The way that we characterize potency is looking at both what's required for the release of the product as well as other characterization that we use for internal learning and improvement as we work on the processes. I can't really go too much into that, but so far, the products that we are manufacturing at CF1 are meeting all the standards to take them into the clinic.

Christine Cassiano: I would now like to turn the call over to Christine Cassiano. You may begin. Thank you operator and welcome to all who have joined this call.

Jack Allen: Hi, Jack. Thanks for the questions.

David Chang: Let me take the manufacturing questions, and I will defer the CLL question to Zach in terms of in a manufacturing. We have successfully manufactured all the products that we are currently investigating in the clinics at CF1. With respect to the details of how we are characterizing, we have a very high standard of characterizing the products that includes the potency. The way that we characterize the potency is looking at both what's required for the release of the product as well as the characterization that we use for the internal learning and for the improvement as we work on the processes.

Speaker Change: Hi, Jack Thanks for the question. So let me take the manufacturing question.

Zach: Sorry, the CLO question too Zach in terms.

Christine Cassiano: After the market closed today, Allogene issue to press release that provides the business update and financial results for the second quarter of 2024. This press release and today's webcast are available on our website. Following our prepared remarks, we will host a Q&A session. We recognize that historically, questions have been multifaceted, but note that we will endeavor to keep this call to under an hour.

Speaker Change: Manufacturing we have successfully.

Speaker Change: Manufactured all of the products that we are currently investigating in the clinics.

Speaker Change: CF plan.

Speaker Change: With respect to the details how we are characterizing we have a very high standard of characterizing that.

Speaker Change: The products.

Christine Cassiano: 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 Jeff 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 presentations, regulatory filings, future research and development efforts, manufacturing capabilities, the safety and efficacy of our product candidates, commercial market forecast, and 2024 financial guidance among other things.

Speaker Change: It includes the put to sea.

Speaker Change: Away that we characterize the potency is.

Jack Allen: Looking at both.

Jack Allen: What's required for the release of the product as well.

Jack Allen: The characterization that we used for the internal learning and <unk>.

Jack Allen: The improvement as we.

David Chang: You know, it can really go too much into that, but so far the products that we are manufacturing at CF1 is meeting all the standards out to take it into the clinics.

Jack Allen: Work on the processes.

Jack Allen: Can't really go too much into that but so far the product set.

Jack Allen: Any factoring at CF, finding it's meeting all of the standard to take it into the clinic.

Zachary Roberts: And Jack, I can address your question on CLL. So, you know, we are obviously pouring most of our efforts and attention into the Alpha 3 program, and, you know, CLL continues to run alongside. And so, as we look towards that data update in early 2025, again, I would say you set the expectations, you know, roughly around the same target number of patients with as much follow-up as we can generate.

Zachary Roberts: And Jack, I can address your question on CLL. So, you know, we are obviously importing most of our efforts and attention into the alpha 3 program, and CLL continues to run alongside. And so, as we look towards that data update and in the early 2025, again, I would say, you set the expectations roughly around the same target number of patients with as much follow-up as we can generate.

Jack Allen: And Jack I can address your question on <unk>. So we are obviously important in most of our efforts and attention into the Alpha three program.

Christine Cassiano: These forward-looking statements are based on current information, assumptions, and expectations that are subject to change. The description of the potential risks can be found in our press release and latest SEC disclosure documents. Your caution not to place under reliance on these forward-looking statements and the alleging explains any obligation to update these statements.

Jack Allen: And CLO continues to run alongside and so as we look towards that data update in early 2025 again I would say you set the expectations roughly around the same target number of patients with as much follow up is we can generate.

David Chang: I'll now turn the call over to David. Thank you Christine and welcome to those on the call today. We hope you all enjoy the pleasant summer so far.

Operator: Thank you.

Lana Astica: Please stand by for our next question. Our next question comes from Lana Astica, Gone Wardening, which is true with Yelana's open.

Operator: Please stand by for our next question. Our next question comes from Asthika Goonewardene with Truist. Your line is open. Hey guys.

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

Jack Allen: Thank you.

David Chang: As I think about the first half of 2024 for halogen, the word that continually comes to mind is momentum. Earlier in 2024, we reset the clinical development plan by advancing semicell, our lead CD19 alokarty product into an LBCL first-line consolidation study, and announced our decision to develop and advance the next generation alokarty product. Alok 329 into autoimmune indications, thereby placing halogen in an enviable position of having clinical programs in team malignancies, solid tumors, and autoimmune indications.

Speaker Change: Please standby for our next question.

David Chang: Asthika, this is David. Let me take on that question. You know, what you are asking is a very important question, but I think it's too early to sort of, you know, lay out, you know, what, how we are thinking about lymphodepletion. It is, it will be, you know, one of the primary focus of Phase 1, exploring the different lymphodepletions, as well as looking at ways to reduce the, you know, the lymphodepletion that's currently being used But what we know from the 3 to 9, you know, with a dual CD19, CD70 approach, we do have many different options that are available in the study design to test this important question.

Africa: Our next question comes from the line of Africa.

Speaker Change: <unk> gone Watney matures Youre line is open.

David Chang: Hi, guys. Good evening, and thanks for taking my questions, and I forgot to get a note as well on the progress. On, I want 3 to 9; the potential to reduce or eliminate limitation is obviously very attractive, but it might be also important to distinguish between those two words. So, here's to know how many patients do you think you'll need to treat with 3 to 9 to actually figure that out. And do you think we might have an answer to that in 2025 from your first treat out on the study?

Speaker Change: Hey, guys good evening and thanks for taking my questions and congrats again on the progress.

Speaker Change: Our 329.

Speaker Change: Potential to reduce or eliminate nimble depletion was obviously very attractive but it might be also importantly distinguish between those two words.

Speaker Change: How many patients do you think youll need to treat.

Speaker Change: With $3 nine to actually figure that out and do you think I have an answer for that in 2025 and your first readout on this study.

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. All right. Thank you.

Asthika Goonewardene: Asthika, this is David. Let me take on that question. You know, what you are asking is a very important question, but I think it's too early to sort of, you know, lay out, you know, what, how we are thinking about lymphodepletion. It is, it will be, you know, one of the primary focus of Phase 1, exploring the different lymphodepletions, as well as looking at ways to reduce the, you know, the lymphodepletion that's currently being used But what we know from the 3 to 9, you know, with a dual CD19, CD70 approach, we do have many different options that are available in the study design to test this important question.

David Chang: Astica, this is David. Let me take on that question. You know, what you are asking is a very important question, but I think it's too early to sort of, you know, lay out, you know, what, how we are thinking about the lymphatic lesion. It is, it will be, you know, one of the primary focus about phase one, you know, exploring the different lymphatic lesion as well as looking the ways to reduce the, you know, the lymphatic lesion that's currently being used in the hotel city, 19 car, tea, trials, you know, the immune. But what we know from the 3 to 9, you know, with a dual city, 19 city, 70 approach, we do have many different options that are available in the study design to test, you know, the, this important question.

Speaker Change: Yes.

Speaker Change: This is David let me take on that question.

David Chang: Hard work creates opportunities, but external factors must line up to create and build momentum. As we think about the two programs, we get asked about most often alpha three with semicell and alok 329 in autoimmune momentum is on our side. To be clear, this does not mean that it has been easy. Our team is working harder than ever. But that same hard work and dedication, along with the bold choices we made over the last year, set up a chain reaction that we see daily as we work with investigators and external stakeholders on our program.

Speaker Change: <unk> important question, but I think it's too early to sort of.

Speaker Change: Lay out what how we are thinking about tailwind for depletion. It is it will be one of the primary focus about phase one exploring this differently for completion as well as looking for ways to reduce.

Speaker Change: The lymphoid depletion that's currently being used in the autologous CD 19 car T trials in order to Amy and but what we know from three to nine.

Africa: Your CD 19, CD 70 approach.

Africa: Do have many different options that are available in the study design to test.

David Chang: Williams, simply put the reset that was based on our long-standing conviction on our alo-cardi programs have put us in a position to potentially change the cardkey landscape. Momentum for us is merely starting point. Now that we have shifted strategy into a clear and honorable leadership position, our programs continue to build speed, and it has been remarkable for our lead program of a three. Our spotlight, three measures that may not be as visible to investors as they are to us internally at Allogene.

Speaker Change: This important question.

Operator: Thank you.

Brooke Schuster: Please stand by for our next question. Our next question comes from the line of Sammy Coleman with William Blair, Yalena Sopin. Hi, thank you for taking our question.

David Chang: 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. All right. Thank you.

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

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

Brooke Schuster: Hi, thank you for taking our question. This is Brooke Schuster from SAMHEE. Regarding the community centers, given that these centers are less likely to be less experienced or have no CAR-T experience, are they getting extra training to be prepared for CAR-T treatment, such as recognizing safety signals and ensuring proper MRD testing, etc.?

Operator: Hi, thank you for taking our question. This is Brooke Schuster from SAMHEE. Regarding the community centers, given that these centers are less likely to be less experienced or have no CAR T experience, are they getting extra training to be prepared for CAR T treatment, such as recognizing safety signals and ensuring proper MRD testing, et cetera?

Sami Corman: Hi, Thank you for taking our question I suspect Schuster on for Sandy.

Zachary Roberts: This is Brooke Schuster on for Sammy. So regarding the community centers, given that these centers are less likely to be less experienced or have no CAR-T experience, are they getting extra training to be prepared for CAR-T treatment such as recognizing safety signals and ensuring proper MRD testing, et cetera.

Sami Corman: So regarding the community centers given that these centers are less likely to be like less experience. Our hopper railcar key experience are they getting extra training to be prepared for a car T treatment.

Speaker Change: Recognizing safety signals and ensuring proper MRV testing, etc.

David Chang: First, while the market is not kind to buy tech right now, we strengthened our base of investors in this last round with some of the highest caliber investors any company could hold for. We don't take that for granted. Second, the number of sites who want to participate in our alpha three trial and the energy with which they are engaged can be likened to what we saw in the early days of Othala's Carti.

Zachary Roberts: Hey, Brooke, this is Zach. Thank you for the question. So we approach every site, kind of with the same view in mind, and that is, you know, we want to make sure that they have all the tools and the information they need to safely manage their patients. So for the large academic centers that have been doing CAR for 10 plus years, they would need potentially a little bit less training, although we still do offer that training than somebody who has somewhat less experience or maybe even no experience at all. We feel like we're in a pretty good place starting out because our safety profile for semicell, as we've shown in our phase one study, is actually fairly well tolerated with varied little, in fact, no high-grade CRS or ICANNs, sort of an infection profile that is very consistent with patients who are receiving treatment for various different types of cancer.

Zachary Roberts: Hey Brooke, this is Zach. Thank you for the question. So, we approach every site kind of with the same view in mind, and that is, you know, we want to make sure that they have all the tools and the information they need to safely manage their patients. So, for the large academic centers that have been doing CAR for 10 plus years, they might need potentially a little bit less training, although we still do offer that training, than somebody who has somewhat less experience or maybe even no experience at all.

Samantha Corwin: Hey Brooke, this is Zach. Thank you for the question. So we approach every site kind of with the same view in mind, and that is, you know, we want to make sure that they have all the tools and the information they need to safely manage their patients. So for the large academic centers that have been doing CAR for 10 plus years, they would need potentially a little bit less training, although we still do offer that training, than somebody who has somewhat less experience or maybe even no experience at all.

Speaker Change: Hey, Brett this is Jack.

Brett: You for the question.

Brett: So we approach every every site kind of what's the same view in mind and that is we.

Brett: We want to make sure that they have all the tools and the information they need to safely manage their patients. So for the large academic centers that have been doing car for 10 plus years, they would need potentially a little bit less training, although we still do offer that training than somebody who has somewhat less experience or may be even.

David Chang: There seems to be on the current of understanding that this trial has the potential to forever change their practices. Third, the collaborative engagement from the FDA on this trial has been illuminating. We believe we have achieved support for alpha three based on three key benefits that stem from the innovative study design. One, advancing Carti into early line setting maximizes the curative potential of the variability. Two, treating minimum residual disease or MRD, the lowest disease volume one can measure has the potential to make Carti safer and more effective.

Zachary Roberts: We feel like we're in a pretty good place starting out because our safety profile for SEMICEL, as we've shown in our Phase 1 study, is actually fairly well tolerated with very little, in fact, no high-grade CRS or ICANNs, sort of an infection profile that is very consistent with patients who are receiving treatment for various different types of cancer. So, you know, from the perspective of training specific to the management of CAR-T side effects, we're starting up with a leg up already.

Samantha Corwin: We feel like we're in a pretty good place, starting out, because our safety profile for SEMICEL, as we've shown in our Phase 1 study, is actually fairly well tolerated with very little, in fact, no high-grade CRS or ICANNs, sort of an infection profile that is very consistent with patients who are receiving treatment for various different types of cancer. So, you know, from the perspective of training specific to management of CAR T side effects, we're starting up with a leg up already.

David Chang: And three, using MRD to select and treat only the patient who will likely experience recurrence makes alpha three design very efficient. Concentrating treatment in only the patient population who needs it and leaving everybody else alone. We believe these key points are well aligned with abuse of FDA and other key stakeholders. We aim to validate the support for this trial.

Speaker Change: No experience at all.

Speaker Change: We feel like we're in a pretty good place starting out because our safety profile for <unk> as we've shown in our phase one study is.

Speaker Change: Actually fairly well tolerated with very little in fact, no high grade Crs or I can.

Speaker Change: Sort of an infection profile that is very consistent with patients who are receiving treatment for various different types of cancer.

Zachary Roberts: So, you know, from the perspective of training specific to management of CAR-T side effects, you know, we're starting up with a leg up already. I will also add that many, if not all, of these community centers are familiar with CRS and ICANNs and other T cell-mediated adverse events because they've been giving by specific therapy for LBCL and other cancers now for, you know, months or even years if they were open for trials. So these are not truly naive centers. They stocked hostelism ab in their pharmacies, et cetera. So we actually feel like this should be fairly manageable, but it's a good question, and we are making sure that each center is fully trained to handle this safely.

Speaker Change: So from the from the perspective of training specific to management of car T side effects.

Speaker Change: Starting up with a leg up already.

Samantha Corwin: I will also add that many, if not all, of these community centers are familiar with CRS and ICANNs and other T cell-mediated adverse events because they've been giving bispecific therapy for LBCL and other cancers now for months or even years if they were open to trials. So, these are not truly naive centers.

Zachary Roberts: I will also add that many, if not all, of these community centers are familiar with CRS and ICANNs and other T-cell mediated adverse events because they've been giving bispecific therapy for LBCL and other cancers now for months or even years if they were open to trials. So, these are not truly naive centers.

Speaker Change: I will also add that many if not all of these community centers are familiar with Crs and ICANN and other T cell mediated adverse events because they have been giving.

Speaker Change: By specific therapy for <unk> and other cancers now for months or even years. If they were opened for trials. So these are not truly naive centers. They stocked socialism app in their pharmacies et cetera. So we actually feel like this should be fairly manageable, but it's a good question and we are making sure that each center.

Zachary Roberts: They stock Tocilizumab in their pharmacies, et cetera. So, we actually feel like this should be fairly manageable, but it's a good question, and we are making sure that each center is fully trained to handle this safely. You also asked about collecting the MRD test. So, I'm proud to say that this is actually a fairly straightforward test that these sites will have to collect. In fact, it's very similar in terms of what they have to do on their side to just about any other test that is collected now for lung cancer or breast cancer. There's a piece of tumor that is sent in, and then a blood test, and then Foresight handles the rest. So, that should hopefully have very few errors or any difficulties.

David Chang: We have also continued to strengthen averaging even if not in the spotlight or something that honors headlines to ensure that we can deliver on our promises such as the work done in our self-forged one facility in the East Bay where we now manufacture all of our Carti investigational product. This significantly minimizes our reliance on contract manufacturers for the products and provides algae with a critical strategic asset for manufacturing capacity to serve the market that we are addressing in our trials. As the month continues, I am confident that this exceptional momentum we feel internally will become increasingly evident to the outside world.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Matthew Biegler with Oppenheimer. Your line is open.

Speaker Change: <unk> is fully trained to handle this safely you also asked about <unk>.

Zachary Roberts: You also asked about the collection of the MRD tests. So I'm proud to say that this is actually a fairly straightforward test that these sites will have to collect. In fact, it's very similar in terms of what they have to do on their side to just about any other test that is collected now for lung cancer, breast cancer. There's a piece of tumor that is sent in, and then a blood test, and then Foresight handles the rest. So that should hopefully have very few errors or any difficulties.

Speaker Change: Collection of EMR detail so.

Speaker Change: I'm proud to say that this is actually a fairly straightforward test that.

Speaker Change: That these sites will have to collect in fact, it's very similar in terms of what they have to do on their side to just about any other test that is collected now for lung cancer and breast cancer.

Speaker Change: Piece of tumor that has Santana and then a blood test and then fore sight handles the rest so that should hopefully have very few errors or any difficulties.

Operator: Thank you. Please stand by for our next question.

Speaker Change: Thank you ladies standby for our next question.

Matthew Beegler: Our next question comes from the line of Matthew Beegler with Oppenheimer. Yaline is open. Hey guys, thanks for a question.

Speaker Change: Our next question comes from line of.

Zachary Roberts: I will now turn the call over to Zach to discuss the program's of most significant interest to investors. Thank you, David. As most of you know, our development focus in 2024 has been on our four core programs, Semacell for First Line Consolidation and LBCL and Relapse for Factory CLL, ALO 329 in Autoimmune and ALO 316 in Renal Cell. Carl Carcinoma, while our CLL and renal cell programs continue to move forward as planned, with a meaningful update from the RCC trial planned by year end, I will focus my remarks today on the two programs that we get most asked about.

Speaker Change: Matthew Biegler with Oppenheimer. Your line is open.

Matthew Biegler: Hey guys, thanks for the question. It's great to be back. I wanted your opinion on the importance of T cells and their contribution to certain autoimmune diseases. It seems, you know, obviously, as an industry, we're singularly focused on the B-cell reset, but I guess, you know, with some of the data mentioned that you are on relapses, I'm just curious. It seems like your Dagger technology not only can maybe do away with lymphoconditioning but also target reactive T cells. So just kind of curious, like, if you think you might have an edge over other players in the autoimmune space. Thanks.

Matthew Biegler: Hey guys, thanks for the question. It's great to be back.

David Chang: It's great to be back. Wanted to your opinion on the importance of T cells and contributing to certain autoimmune diseases. It seems, you know, obviously like an industry where singularly focused on the B cell reset, but I guess, you know, with some of the data mentioned that you are on relapse as I'm just curious. You know, it seems like your dagger technology not only can maybe do away with limpo conditioning, but also target reactive T-cells.

Matthew Biegler: Hey, guys. Thanks for the question great feedback.

Speaker Change: In your opinion on the importance of T cells and contributing to certain autoimmune diseases. It seems obviously like.

Speaker Change: And industry were singularly focused on the B cell reset, but I guess with some of the data I mentioned that you are on relapses I'm just curious.

Speaker Change: It seems like Youre dagger technology, not only can maybe do away with limbo conditioning, but also target reactive T cell phone just kind of curious like.

David Chang: So just kind of curious, like if you think you might have an edge on other players in the autoimmune space. Thanks.

Speaker Change: If you think you might have an edge.

Speaker Change: Other players in the autoimmune space.

David Chang: Hey, Matthew, great to have you back. And you know, very important question as we think about the Carties in the autoimmune space. I mean, you know, I think we have to start, you know, design of the product. You know, thinking about this disease from the fundamental biologic perspective, you know, autoimmune disease is never a disease of in a B-cells. It's always in a D-B-cells and contributing T-cells that really, you know, eventually manifest the symptoms of autoimmune diseases. So from that perspective, we felt being able to target activated T-cells. And we achieved that by going after C-cells.

David Chang: Hey Matthew, great to have you back.

David Chang: I wanted your opinion on the importance of T cells and their contribution to certain autoimmune diseases. It seems, you know, obviously, as an industry, we're singularly focused on the B-cell reset, but I guess, you know, with some of the data mentioned that you are on relapses, I'm just curious. It seems like your Dagger technology not only can maybe do away with lymphoconditioning but also target reactive T cells. So just kind of curious, like if you think you might have an edge on other players in the autoimmune space, thanks.

Speaker Change: Hey, Matthew Great to have you back and very important question as we think about the car Ts in autoimmune space.

Zachary Roberts: I'll start with our lead program, semisel and the alpha-3 trial which we initiated in June. In just a few weeks following the investigational device exemption or IDE approval in mid-June, we've opened the first 10 community and academic cancer centers and have been successfully screening patients. The speed with which we've been able to bring community cancer centers into the trial, in particular, speaks volumes that we're going to focus on today. This brings for what this may mean commercially and reinforces our belief that an Allogeneate CAR-T option will be what opens the door to this modality for these centers where most patients are treated.

Speaker Change: I think we have to start the design of the product thinking about this disease from the fundamental biologic perspective.

Speaker Change: Auto immune diseases is never a disease.

Speaker Change: So it's always the b cells and contributing T cells.

Speaker Change: Really eventually manifest symptoms of autoimmune diseases. So from that perspective, we felt being able to target activated T cells, and we achieved that by going after <unk> 70, which I expressed on activated T cells. We believe that this is Barry.

David Chang: And, you know, a very important question as we think about CAR T's in the autoimmune space. I mean, you know, I think we have to start, you know, designing the product, you know, thinking about this disease from a fundamental biological perspective. You know, autoimmune disease is never a disease of B cells. It's always B cells and contributing T cells that really, you know, eventually manifest themselves in autoimmune diseases.

Zachary Roberts: First line chemo immunotherapy for LBCL has largely gone unchanged for a quarter century and for good reason. Our chop and similar regimens work pretty well with the majority of patients achieving cure with this easy to give safe regimen. However, approximately one-third of patients with LBCL whose disease initially responds to our chop will experience relapse. Alpha-3 is a groundbreaking trial for two reasons. First, it is the first prospective trial that will utilize an ultra-sensitive biomarker to inform physicians and patients whether the cancer is likely cured by first line our chop or if the disease will likely recur and require second line treatment or beyond.

David Chang: So in the D-70, which I expressed on the activated T-cells, we believe that this is very important to maximize the, you know, potential of all three to nine across different autoimmune education. So yes, we have to show it in a clinical data, but it definitely increases the potential of all three to nine versus, you know, car key programs that are simply targeting B-cells. Thank you.

Speaker Change: Important to maximize the potential.

Speaker Change: Our 329 across different autoimmune indications so yes, we have.

David Chang: So, from that perspective, we felt like being able to target activated T cells, and we achieved that by going after CD70, which I expressed on the activated T cells. We believe that this is very important to maximize the potential of IL-329 across different autoimmune indications. So, yes, we have to show it in a clinical data set. But, you know, clinical data, but it definitely increases the potential of IL-329 versus, you know, CAR T programs that are simply targeting B cells.

Speaker Change: To show, even the clinical data, but it definitely increases the potential.

Zachary Roberts: And second, Alpha-3 is the first trial to propose a treatment, namely a dose of semisel for remission consolidation, specifically for those patients who are likely to face a future relapse. If positive, Alpha-3 could mark the beginning of a new era in LBCL treatment, potentially supplanting the current standard of care after frontline treatment, which has for decades been to watch and wait for the disease to relapse. We believe our partnership with Forsyte Diagnostics, who is developing a novel and potentially practiced changing tests for minimal residual disease, will change that.

Speaker Change: <unk> nine <unk>.

Speaker Change: Is <unk>.

Speaker Change: Car T programs that are simply targeting b cells.

David Chang: Hey Matthew, great to have you back.

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

John Newman: Please stand by for our next question. Our next question comes from the line of John Newman with Canacor, Yalena Sullivan. Hi guys, congrats on the progress, and thanks for taking my question. So David, we've seen some data recently from two targets, Cartie programs in the autoimmune setting, which I'm sure everybody on the call is very familiar with.

Speaker Change: Thank you ladies standby for our next question.

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

John Newman: Hi, guys. Congrats on the progress, and thanks for taking my question.

John Newman: Hey, guys congrats on the progress and thanks for taking my question. So David we've seen some data recently from two targets.

David Chang: So, David, we've seen some data recently from two autologous CAR-T programs in the autoimmune setting, which I'm sure everybody on the call is very familiar with. My question is, is there something different beyond the targeting of active T cells for Allo329, for example, manufacturing or another aspect, that you think could result in more consistency?

John Newman: Car T programs in the autoimmune setting, which I'm sure everybody on the call is very familiar with my question is.

David Chang: My question is, is there something different beyond the targeting of active T-cells for all three to nine, for example, manufacturing or another aspect that you think could result in more consistent results when you run the study. I think we're all trying to figure out exactly what the autologist data mean, but what I'm curious about is, is there something specific perhaps in the manufacturing process or somewhere else for three to nine that could give more consistent results in the future. Thanks.

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

Speaker Change: Is there something different.

Speaker Change: Beyond the targeting of accurate T cells for Al III for example, manufacturing or another aspect.

John Newman: Hi guys, congrats on the progress and thanks for taking my question.

Speaker Change: That you think could result in more consistent results. When you run the study I think we're all trying to figure out exactly what the autologous data, meaning but I'm curious about is.

Zachary Roberts: This investigational test, when administered following the completion of frontline treatment for LBCL, has the potential to offer a highly accurate prediction of future disease relapses. Alpha-3, therefore, offers something to all patients who screen. If the screening MRD test is positive, you are potentially eligible to receive a dose of CAR-T cells designed to eradicate the residual disease, hopefully attaining the cure, which remained elusive after our chop. If the screening MRD test is negative, it could provide assurance that your disease has been fully cured.

David Chang: more consistent results when you run the study. I think we're all

David Chang: I'm trying to figure out exactly what the autologous data mean, but what I'm curious about is... Is there something specific in the manufacturing process or somewhere else for 329 that could give more consistent results in the future? Thanks.

David Chang: David, we've seen some data recently from two autologous CAR-T programs in the autoimmune setting, which I'm sure everybody on the call is very familiar with. My question is, is there something different beyond the targeting of active T cells for IL-329, for example, manufacturing, or another aspect that you think could result in more

Speaker Change: Is there something specific perhaps in the manufacturing process or somewhere else for three to nine that could give them more consistent results in the future. Thanks.

David Chang: Hi John, thanks for that excellent question. I mean, the manufacturing at the end is one of the big differences that can result in the difference in the outcome. We don't have all the details of, you know, how different programs that have taken City 19 Cartie into the autoimmune space, you know, have been manufactured, but definitely, you know, we do strongly believe that how the cells are prepared, you know, what do the cells frozen before administration or administered without freezing, all these things together with, you know, the way that the cells are being treated. It's like expanded, you know, makes a big difference.

David Chang: More consistent results when you run the study.

David Chang: Hi John. Thanks for that excellent question. I mean, you know, the manufacturing at the end is, you know, one of the big So, there are a lot of differences that can result in a difference in the outcome. We don't have all the details of how different programs that have taken CD19 CAR-T into the autoimmune space have been manufactured, but we definitely do strongly believe that how the cells are prepared, whether the cells are frozen before administration or administered without freezing, all these things together with the way that the cells are expanded make a big difference.

John: Alright, John.

Speaker Change: Thanks for that excellent question.

Speaker Change: Manufacturing SDN is one of the big.

Zachary Roberts: Peace of mind after a life-altering diagnosis and its treatment cannot be underestimated. Importantly, Alpha-3 builds on the growing understanding that administering CAR-T therapies to patients with low disease burden can improve safety and efficacy outcomes. The industry has presented research that illustrates this point. Semicell's Phase-1 Safety Profile with low rates of CRS and ICANNs already permits its use in the outpatient setting in relapse for fractory patients, and may further improve in patients with no radiological evidence of disease.

Speaker Change: Big differences that can result in the difference in the outcome.

Speaker Change: We don't have all the details.

Speaker Change: How different.

Graham: Graham instead have taken the CD 19 car T into the autoimmune space.

Speaker Change: <unk> been manufactured but.

John: Currently we do strongly believe that how the cells prepared whether the cells.

John: Then before administration or administered without freezing all these things together with the way that the cells I expanded that makes a big difference.

Zachary Roberts: Combine this with the elimination of complex logistics that have hindered CAR-T adoption, as well as the reliance on referrals, and we have, as David rightly noted, a clear momentum effect for the Alpha-3. Jessica Three Child with Investigators. As we have noted in previous calls, the outcome of this pivotal trial could allow Semicel to be embedded in the first line setting where autologous therapies are far less feasible. Consolidating response with an MRD positive result post our job requires immediate and definitive action to prevent an impending relapse.

David Chang: Unfortunately, the details are somewhat lacking because the information, some are kept as proprietary information, but I think that is a very important question as for the in a three to nine. You know, we have taken a different approach of manufacturing, you know, fundamentally, how we introduced the trans chain that expressed our car, whether we do lentifiers. We have in this case taken the path of doing such specific integration using CRISPR based a nucleus and AAB. And you know, study section on that kind of approach can potentially improve the consistency of the final product, which we believe is very important as we think about indications such as autoimmune.

Speaker Change: Unfortunately, the details are somewhat lacking because the inflammation somewhat kept as a proprietary information, but I think that is a very important question as for the $32 nine.

David Chang: Unfortunately, the details are somewhat lacking because the information is somewhat kept as proprietary information, but I think that is a very important question. As for the 329, we have taken a different approach to manufacturing. How we introduced the transgene that expressed CAR, whether we used lentivirus, we have, in this case, taken the path of doing site-specific integration using CRISPR-based nuclease and AAV, and studies have shown that this kind of approach can potentially improve the consistency of the final product, which we believe is very important as we think about indications such as autoimmune, so stay tuned.

David Chang: You run the study. I think we're all trying to figure out exactly what the autologous data mean, but what I'm curious about is, is there something specific in the manufacturing process or somewhere else for 329 that could give more consistent results in the future? Thanks.

Speaker Change: Taking a different approach up manufacturing fundamentally.

David Chang: Hi John. Thanks for that excellent question. I mean, you know, the manufacturing at the end is one of the big differences that can result in a difference in the outcome. We don't have all the details of how different programs that have taken CD19 CAR-T into the autoimmune space have been manufactured, but we definitely do strongly believe that how the cells are prepared, whether the cells are frozen before administration or administered without freezing, all these things together with the way that the cells are expanded make a big difference.

John: How we introduced trends change that express a car whether we do lentivirus, we have in this case taken the path doing site specific integration using.

David Chang: Unfortunately, the details are somewhat lacking because the information is somewhat kept as proprietary information, but I think that is a very important question. As for the 329, we have taken a different approach to manufacturing. Fundamentally, how we introduced the transgene that expressed CAR, whether we used lentivirus, we have, in this case, taken the path of doing site-specific integration using CRISPR-based nuclease and AAB. Studies have shown that this kind of approach can potentially improve the consistency of the final product, which I believe is very important as we think about indications such as autoimmune. So stay tuned.

Zachary Roberts: Relapse is tend to occur quickly after completion of our job 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. We bring to the table a truly differentiated CAR-T offering that has the potential to break open an untapped market. You can say that. The first indication of how the trial is proceeding will be when we announce the selection of the Lympho-depletion Regimen, we will continue to the end of the trial.

Speaker Change: Using CRISPR based on new plays and AAV and.

Speaker Change: Our studies have shown that kind of approach can potentially improve consistency at the final product, which we believe is very important as we think about indications such as auto immune so stay tuned.

David Chang: So stay tuned.

Operator: Thank you.

Benjamin Burnett: Please stand by for our next question. Our next question comes from the line of Ben Burnett with Steve Fulk. Your line is open. Hey, thank you very much. I also wanted to ask about all of 329 and other immune diseases. There's a recent disclosure with a CD-19 allogeneic CAR-T from BRL Medicine. It was via an academic study in China, but without the data, look quite good. That BRL asset, though, it contained a number of edits and modifications.

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

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

Speaker Change: Thank you.

Speaker Change: Standby for our next question.

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

Zachary Roberts: That announcement is expected in mid 2025. The next study milestones will come less than a year later. We expect a complete enrollment in first half of 2026. The prognosis for patients who are MRD positive at the end of front line therapy is quite poor, so study events are expected to come in quickly. Therefore, we expect to perform efficacy analyses in 2026 as well. This will include an independent data safety monitoring board interim efficacy analysis in the first half of 2026. In the data readout of the primary analysis year end 2026. If the trial is successful, we expect to follow these data readouts with a biologics license application submission in 2027.

Alana Bindernat: Hey, thank you very much. I also wanted to ask about ALO329 and autoimmune diseases. There was a recent disclosure of a CD19 allogeneic CAR-T from BRL Medicine. This was via an academic study in China, but we thought the data looked quite good. That BRL asset, though, contained a number of edits and modifications. So I guess the question is, number one, it'd be great to get kind of your thoughts on that data. And secondly, I guess, how does the technology that you're implementing with ALO329 with Dagger and everything else sort of compare to that BRL asset?

Benjamin Burnett: Thank you very much. I also wanted to ask about Allo329 and autoimmune diseases. There was a recent disclosure of a CD19 allogeneic CAR-T from BRL Medicine. This was via an academic study in China, but we thought the data looked quite good. That BRL asset, though, contained a number of edits and modifications. So I guess the question is, number one, it'd be great to get kind of your thoughts on that data. And secondly, how does the technology that you're implementing, with Allo329, with Dagger, and everything else sort of compare to that BRL asset?

Ben Burnett: Hey, Thank you very much I also wanted to ask about allo through two nine in autoimmune disease.

Speaker Change: There is a recent disclosure with a CD 19, allogeneic car T from BRL medicine.

Speaker Change: This was a it was via an academic study in China, but we thought the data looked quite good.

Speaker Change: B R L asset, though it contained a number of edits and modifications. So I guess the question is number one it would be great to get kind of your thoughts on those data and just secondly, I guess, how does the technology that you're implementing.

David Chang: So I guess the question is number one; it would be great to get your thoughts on those data. And just secondly, I guess how does the technology that you're implementing and with all of 329 would dagger and everything else sort of compare to that BRL asset. Then this is that.

Speaker Change: With allo <unk> with Dougherty.

Speaker Change: And everything else sort of compare to that Bureau asset.

Zachary Roberts: This is Zach. Thanks. Very insightful question and thanks for bringing up that exciting report. So we share, I think, the enthusiasm around that first report of responses to a CD19 allogeneic CAR-T in three patients with two different autoimmune indications. We feel that that is a very strong proof of concept that this platform, which we have demonstrated is functional in oncology, is likely to also be operable in autoimmune disorders. You rightly highlight some of the strategies that they have employed to ensure adequate expansion and persistence.

Zachary Roberts: And this is Zach. Thanks. A very insightful question.

David Chang: Thanks, very insightful question. And thanks for bringing up that exciting report. So we share, I think, the enthusiasm around that first report of responses to a CD-19 allogeneic CAR-T in three patients with two different autoimmune indications. We feel that that is a very strong proof of concept that this platform, which we have demonstrated is functional and oncology, is likely to also be operable in autoimmune disorders. You rightly highlight some of the strategies that they have employed to ensure adequate expansion and persistence. They have taken what might be called a sort of a cloaking strategy where they've eliminated MHC molecules and they've also disrupted the PD-1 axis.

Ben Burnett: Ben This is <unk>. Thanks, very insightful question and thanks for bringing up that exciting report. So we share I think the enthusiasm around that first report of responses to CD 19, Allogeneic car T and.

Zachary Roberts: I'll now discuss ALO-329. Differentiation is critical across our core programs. We declared our move into the autoimmune space with the goal of resetting the immune system with a single infusion. ALO-329, our next generation CD19 CD70 dual car, incorporates our dagger technology, CRISPR-based gene editing, and site-specific car-transduring integration, and is rationally designed to meet the unique needs of patients with autoimmune disease. Our dagger technology provides a potential path to reducing or eliminating lymphatic lesion, which we believe may create more development and commercial opportunities for ALO-329 in autoimmune indications.

Speaker Change: And three patients with two different autoimmune indications, we feel that that is a very strong proof of concept that this platform, which we have demonstrated as is functional and oncology is likely to also be operable in autoimmune disorders.

Zachary Roberts: And thanks for bringing up that exciting report. So we share, I think, the enthusiasm around that first report of responses to a CD19 allogeneic CAR-T in three patients with two different autoimmune indications. We feel that that is a very strong proof of concept that this platform, which we have demonstrated is functional in oncology, is likely to also be operable in autoimmune disorders. You rightly highlight some of the strategies that they have employed to ensure adequate expansion and persistence.

Speaker Change: You rightly highlight some of the strategies that they have employed two to ensure adequate expansion and persistence.

Zachary Roberts: They have taken what might be called a sort of a cloaking strategy where they've eliminated MHC molecules, and they've also disrupted the PD-1 axis. This is a strategy that has been tried by others, and I think it's probably still too early to say whether that is, you know, globally speaking, a successful path. Our plan relies on Dagger technology to ensure that we do get that adequate expansion and persistence, and we feel very comfortable that this sort of Dagger versus the cloaking strategy will deliver benefits, and we've seen this now in the RCC program with the Allo 316 product, where we get up to two logs better expansion and improved persistence even with a de-intensified lymphodepletion regimen. I think every allogeneic platform is going to have to deal with the idea of premature rejection, and we are very confident that the Dagger is going to give us a path forward.

Zachary Roberts: They have taken what might be called a sort of a cloaking strategy where they've eliminated MHC molecules, and they've also disrupted the PD-1 axis. This is a strategy that has been tried by others, and I think it's probably still too early to say whether that is, you know, globally speaking, a successful path. Our plan relies on Dagger technology to ensure that we do get that adequate expansion and persistence, and we feel very comfortable that this sort of Dagger versus the cloaking strategy will deliver benefits, and we've seen this now in the RCC program with the Allo 316 product, where we get up to two logs better expansion and improved persistence even with a deintensified lymphodepletion regimen. I think every allogeneic platform is going to have to deal with the idea of premature rejection, and we are very confident that the Dagger is going to give us a path forward.

Speaker Change: They have taken what might be called a sort of a cloaking strategy where they've eliminated.

Zachary Roberts: We are on track to file an IND in Q1 of 2025 and open the trial to enrollment by mid 2025. As a result, we expect to have proof of concept in this trial by the end of 2025. We recognize that highest clinical proof of concept is enlupus, but we also know the importance of differentiation. In the path we are taking provides us a luxury of time to define the best approach while leveraging proof of concept data from other trials to consider other indications with unmet needs.

Speaker Change: MHC molecules and they've also.

Ben Burnett: Disrupted the PD one axis.

David Chang: This is a strategy that has been tried by others. And I think that it's probably still too early to say whether that is globally speaking a successful path.

Speaker Change: This is <unk>.

Ben Burnett: Strategy that has been tried by others and I think it's probably still too early to say whether that is.

Ben Burnett: Globally speaking a successful path our plan.

David Chang: Our plan, it has relied on the dagger technology to ensure that we do get that adequate expansion and persistence. And we feel very comfortable that this sort of dagger versus the cloaking strategy will deliver benefits. And we've seen this now in the RCC program with the ALO-316 product where we get up to two logs, better expansion and improved persistence, even with the de-intensified lymphotoclesian regimens. So I think every allogeneic platform is going to have to deal with the idea of premature rejection. And we are very confident that the dagger is going to give us a path forward there.

Speaker Change: It has relied on the dagger technology to ensure that we do get that adequate expansion and persistence and we feel very comfortable that this sort of data versus the <unk> strategy.

Zachary Roberts: We expect to provide more detail on our development plan by the end of the year and appreciate the feedback many of you have provided as we chart this course.

Speaker Change: <unk> will deliver benefits and we've seen this now.

Speaker Change: The RCC program with the Allo 301, sixth product, where we get up to two logs better expansion and improved persistence.

Speaker Change: Even with the de intensified lymphoid depletion regimen. So I think every allogeneic platform is going to have to deal with the.

Speaker Change: The idea of premature rejection and we are very confident that the diagnose kind of give us a path forward there.

Luca Issi: Thank you. Please stand by for our next question. Our next question comes from the line of Luca. Is he with RBC Capital? Yalan is open. Oh, great. Thanks so much for a thing. My question is, congrats on the progress.

Operator: Please stand by for our next question. Our next question comes from the line of Luca Issi with RBC Capital. Your line is open.

Speaker Change: Thank you.

Jeff Parker: Allogene is in a unique position. We control the only clinically validated Allogeneity CD-19 CARTI product positioned to transform how and where CARTIs are used in HEME mullignancies. The recognition for this will only grow over the next six to 12 months as the Alpha 3 program is de-risked.

Speaker Change: Please standby for our next question.

Operator: Please stand by for our next question. Our next question comes from the line of Luca Issi with RBC Capital. Your line is open.

Lukas <unk>: Our next question comes from the line of Lukas <unk> with RBC capital. Your line is open.

Luca Issi: Well, great. Thanks so much for taking my questions. Congratulations on the progress. Maybe just a quick one, David or Zach.

Lukas <unk>: Oh, great. Thanks, so much for taking my questions. Congrats on the progress maybe just a quick one David exactly.

David Chang: Maybe just a quick one, David or Zach on what's the latest thinking of whether you think that anti-CD-52 was actually needed as part of the lymphotoclesian in ALO-3? I was always under the impression that adding CD-52 was actually important to discriminate between endogenous and exogenous T-cells. But it feels to me that you're maybe downplaying that little bit recently. And maybe you're now thinking that anti-CD-52 may not be needed as part of the pletion. What am I right? And if so, how should we think about the overall profile of your drug in a scenario where anti-CD-52 is needed versus not needed?

David Chang: What's the latest thinking on whether you think that anti-CD52 is actually needed as part of lymph depletion in alpha-3? I was always under the impression that adding CD52 was actually important to discriminate between endogenous and exogenous T cells, but it feels to me that you're maybe downplaying that a little bit recently, and maybe you're now thinking that anti-CD52 may not be needed as part of lymph depletion Juan, am I right? And if so, how should we think about the overall profile of your drug in a scenario where anti-CD52 is needed versus not needed?

David Chang: What's the latest thinking on whether you think that untyped CD52 is actually needed as part of lymph depletion in alpha-3? I was always under the impression that adding CD52 was actually important to discriminate between endogenous and exogenous T cells, but it feels to me that you're maybe downplaying that a little bit recently, and maybe you're now thinking that untyped CD52 may not be needed as part of lymph de Juan, am I right? And if so, how should we think about the overall profile of your drug in a scenario where untyped CD52 is needed versus not needed?

Lukas: What's the latest thinking or whether you think that anti CD 62 was actually needed as part of the lift depletion in alpha three I was always under the impression that adding 62 was actually important to discriminate between endogenous exogenous T cells, but it feels to me that maybe downplayed a little bit recently and maybe you are now thinking and anti CD 52 may not.

Jeff Parker: Let me now turn to our financial highlights. Our cash balance as of the end of Q2 2024 was $444.6 million in cash, cash equivalents and investments, and we reiterate that our cash runway extends into the second half of 2026. Q2 2024 research and development expenses were $50.4 million, which includes $5.3 million in expenses associated with non-cash stock-based compensation. General and administrative expenses in Q2 were $16.1 million, which includes $8.2 million of non-cash stock-based compensation expense.

Speaker Change: <unk> be needed as part of depletion what am I right and if so how should we think about the overall profile of your drug in a scenario where <unk> is.

David Chang: Any thoughts there? Much appreciated. Thank you.

Speaker Change: Need it versus not needed any thoughts there much appreciate it thank you.

David Chang: And Luca, let me take on that question. You know, we do believe the anti-CD52 antibody is very important to create persistence, as we have demonstrated in the relapse refractory setting in a large B-cell lymphoma setting. When it comes to the Alpha 3 study where we are treating minimum residual disease, we are talking about a different clinical setting. These patients have minimal disease, which we do not believe may require, you know, which may not require, you know, the kind of persistence that is needed to treat large-volume disease.

David Chang: And look, let me take on that question. You know, we do believe anti-CD-52 anybody is very important to create the persistence. As we have demonstrated in the relapse refractory, you know, in a large piece of informal setting. When it comes to the, you know, the alpha-3 study where we are treating, you know, minimum residual disease, we are talking about a different clinical setting. These patients have minimal disease, and in which we do not believe may require, you know, which may not require, you know, the kind of persistence that is needed to treat large-volume disease. That's why, you know, we feel that, you know, testing the length of the patient both with and without the CD-52 anybody or L-647 that we are using is an important scientific question.

David Chang: Luca, let me take on that question. You know, we do believe the anti-CD52 antibody is very important to create persistence, as we have demonstrated in the relapse refractory setting in a large B-cell lymphoma setting. When it comes to the Alpha 3 study where we are treating minimum residual disease, we are talking about a different clinical setting. These patients have minimal disease, which we do not believe may require or may not require the kind of persistence that is needed to treat large-volume disease.

Speaker Change: Hey, Luke let me take that question, we do believe anti <unk> two antibody is very important to create the persistence that we have demonstrated in the relapsed refractory.

Jeff Parker: For Q2 2024, our net loss was $66.4 million or $35 per share, including non-cash stock-based compensation expense of $13.6 million, and $5 million in non-cash impairment of long-lived asset expense. For Q2 2024, we continue to expect a cash burn of approximately $200 million. We expect full-year 2024 gap 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.

Speaker Change: Large b cell lymphoma, setting when it comes to.

Speaker Change: The <unk> study, where we are trading in a minimum <unk> disease.

Speaker Change: We are talking about a different clinical setting these patients had minimal disease in which we do not believe may require.

David Chang: That's why, you know, we feel that testing the lymphodepletion both with and without the CD52 antibody or ALO647 that we are using is an important scientific question. And also, you know, by doing the study and as we have designed Alpha 3, it gives us really an opportunity to carefully review and dissect the contribution of ALO647 as a lymphodepletion agent in the MRD setting. So that's a question that is to be, you know, tested.

Speaker Change: Which may not require the kind of persistent studies needed to treat large volume disease.

David Chang: That's why we feel that testing the lymphodepletion both with and without the CD52 antibody or ALO647 that we are using is an important scientific question. And also, by doing the study as we have designed Alpha 3, it gives us a really an opportunity to carefully review and dissect the contribution of ALO647 as a lymphodepletion agent in the MRD setting. So that's a question that is to be tested. In either case, in the Alpha 3 study, we are counting on the outcome as measured by the EFS. And whether we proceed with FC or FCA doesn't really change what we are trying to do with the Alpha 3 study.

Speaker Change: Why we feel that testing deliver depletion, both with and without.

Speaker Change: The <unk> two antibody allo 647 that we are using is an important scientific question and also by doing this study as we have designed a tree. It gives us really an opportunity to carefully review and dissect the contribution of $6 seven.

David Chang: And also, you know, by doing the study as we have designed alpha-3, it gives us a really an opportunity to carefully review and dissect the contribution of 647 for as a limb for depletion in the MRD in a setting. So, that's a question that is to be, you know, tested and, you know, either case in alpha-3 study, you know, we are counting on the, you know, outcome as measured by the EFS. And whether we proceed with FC or FCA doesn't really change in what we are trying to do with Alpha-3 study.

David Chang: And, you know, in either case in the Alpha 3 study, we are counting on the outcome as measured by the EFS, and whether we proceed with the EFC or FCA doesn't really change, you know, what we are trying to do with the Alpha 3 study.

Operator: We'll now open the call for questions. Thank you. Ladies and gentlemen to ask the question, please press star 111 on your telephone, and then wait to hear your name announce.

Speaker Change: For as a lymphoid depletion in the MLP.

Operator: To withdraw your question, please press star 111 again. We ask that you limit yourself to one question per caller.

Speaker Change: So thats a question that has to be tested in either case and offer three study.

Operator: Please stand by while we come out with Q&A roster.

Speaker Change: We are counting on us.

Salveen Richter: Our first question comes from the line of salving risk with Goldman Sachs. Yaline is open. Hi, this is Lydia on preselving. Thanks so much for taking the question.

Speaker Change: As measured by the Etfs and whether we proceed with FC OFC a doesn't really change what we are trying to do with Alpha III study.

Operator: Thank you.

Zachary Roberts: Just on submissile in the frontline consolidation setting, could you speak to any gating factors that might prevent a patient, an MRD positive patient from opting for submissile, and are there any clinical preferences that you're hearing from KOLs, or a setting where this might not be recommended? Thank you so much. Hi, Lydia. This is Zach. Thanks for the question. So if I understood it correctly, you're asking about what a patient may decide if they come back and already bothered whether alpha-3 is the right study for them or not.

Tony Butler: Well, you stand by for our next question. Our next question comes from the line of Tony Butler with Rodman and Renshaw. Your line is open.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Tony Butler with Rotman and Renshaw. Your line is open.

Speaker Change: Thank you.

Speaker Change: Standby for our next question.

Speaker Change: Our next question comes from the line of Tony Butler with Rodman <unk> Renshaw. Your line is open.

Zachary Roberts: Hi. This is Tosh, the son of Tony. David, and that you briefly touched upon this, the embedded testing for patients, and, you know, I'm assuming that this is done very soon after the patient is done with the 6th cycle of chemotherapy. Now, I wonder if you could flesh this out a little bit. For example, you're given that, you know, sometimes this comes back rather quickly for MRD publications. How long it takes for patients to get the results, and additionally, is whether the test is something easy or does the patient need to go to a specialized facility to be tested.

Tashir Hasan: Hi, this is Tashir Hasan on behalf of Tony. David and Zach, you briefly touched upon this, the MRD testing for patients, and I'm assuming that this is done very soon after. The patient is done with the sixth cycle of chemotherapy. Now, I wonder if you could flesh this out a little bit, for example. Given that sometimes this comes back rather quickly for MR-deposited patients, how long it takes for patients to get the results, and additionally, whether the test is something easy, or does the patient need to go to a specialized facility to be tested? Thank you.

Tashdid Hasan: Hi, this is Tashdid Hasan on for Tony. David and Zach, you briefly touched upon this, the MRD testing for patients, and I'm assuming that this is done very soon after. The patient is done with the sixth cycle of chemotherapy. Now, I wonder if you could flesh this out a little bit, for example, given that. You know, sometimes this comes back rather quickly for MRD-positive patients, how long it takes for patients to get the results, and additionally, whether the test is easy, or does the patient need to go to a specialized facility to be tested?

Speaker Change: Hi. This is Josh this is Sean on for Tony.

Speaker Change: Good.

Speaker Change: Please see touched upon this.

Speaker Change: The MLD testing for patients and.

Speaker Change: Assuming that this is done very soon after.

Speaker Change: The patient is done with the six cycle of chemotherapy now I Wonder if you could flesh out session sounds a little bit for example.

Zachary Roberts: So right now, there are no real alternatives for patients who come back MRD positive. There are no approved second-line therapies for patients who are in remission, even if they have an MRD positive result. The only option that they currently have would be in the context of a clinical trial, and the only clinical trial that currently is open for patients who have an MRD positive result at the end of therapy is alpha-3. So it should be a fairly straightforward decision for patients. Thank you.

Speaker Change: Given that.

Speaker Change: Sometimes it comes back rather quickly for amyloid positive patients how long it takes for patients to get the results.

Speaker Change: Additionally.

Speaker Change: Whether the test is something easy or does the patient needs to go to a specialized facility to be tested.

Zachary Roberts: Thank you.

Zachary Roberts: Hi there. This is Zach. So you are absolutely spot on. This is a race against time to, to make sure that we can get the dose of semicell in while the patients are still in remission. And in fact, we think that that speed is actually what makes an allocarty product that's suited for this type of a trial as to the specifics. So first, the patients will get their MRD tests at the centers where the study will be open. So there's no need to go to a specialized place to get the blood drawn. All of that will be collected just as any other clinical trial bio specimen is collected every day in other trials.

Zachary Roberts: Thank you.

Zachary Roberts: Hi there, this is Zach. So, you're absolutely spot on. This is a race against time to make sure that we can get the dose of Semicel in while the patients are still in remission. And in fact, we think that that speed is actually what makes an aloe CAR T product best suited for this type of trial. As to the specifics, first, patients will get their MRD tests at the centers where the study will be open, so there's no need to go to a specialized place to get blood drawn.

Speaker Change: Hi, there.

Speaker Change: This exact so youre absolutely spot on this is a race against time to make sure that we can get the doses.

David Chang: Please stand by for our next question. Our next question comes from the line of branching with JP Morgan. Your line is open. Hey guys, thanks for taking our questions today. Maybe just two on Alpha 3. Can you provide some early initial metric on the screen outrage on MRD positivity? Is it in line with our expectation? And then on the supply side, I just want to follow up on your remarks related to the Salesforce 1 facility.

Speaker Change: <unk> in.

Speaker Change: While the patients are still in remission and in fact, we think that.

Speaker Change: That speed is actually what makes an allo car T product that suited for this type of a trial.

Zachary Roberts: Hi there, this is Zach. So you're absolutely spot on. This is a race against time to make sure that we can get the dose of Semicell in while the patients are still in remission. And in fact, we think that that speed is actually what makes an aloe CAR T product best suited for this type of trial. As to the specifics, first, patients will get their MRD tests at the centers where the study will be open, so there's no need to go to a specialized place to get blood drawn.

Speaker Change: As to the specifics so first the patients will get their <unk> tests at the centers, where the study will be open. So there is no need to go to a specialized place to get.

David Chang: Can you confirm whether the supply now is actively coming from the Salesforce 1 for the Alpha 3? And then I have one quick follow up. Thank you. Hey Brian, this is David Chang. I'll take both of those questions. With respect to the early metrics that we are following for the Alpha 3 study. I mean, you know, we started the study and as we have made a comment in the pre-pair statement, you know, there are 10 active sites that are sending patients for screening and enrollment. The metrics that we follow, I mean, certainly in their internal ones, but now we consider that these are very standard metrics that any clinical operations team would follow. So there's not anything unique.

Zachary Roberts: All of that will be collected just as any other clinical trial biospecimen is collected every day in other trials, and that is then sent in to Foresight, who runs the test. That test, we will have that result back within one to two weeks, hopefully closer to one week in most of these patients, but very, very quickly. The test itself is drawn more or less when the patients come in and get their first follow-up scan after their sixth cycle of RCHOP, so this is a standard of care scan taken between three and, say, six weeks or so after that last dose of chemo.

Speaker Change: The blood drawn all of that will be collected just as any other clinical trial.

Speaker Change: Specimen is collected everyday in other trials and that has been sent in.

Zachary Roberts: And that has been sent in to Forsyth, who runs the test. That test is; we will have that result back within one to two weeks, hopefully closer to one week in most of these patients, but very, very quickly. The test itself is drawn more or less when the patients come in and get their, their first follow-up scan after their sixth cycle of our job. So this is a standard of care scan taken between three and say six weeks or so after that last dose of chemo. If the patient's in a remission, that makes them potentially eligible for alpha three.

Speaker Change: To foresight, who runs the test.

Speaker Change: That test is is we will have that result back within one to two weeks hopefully closer to one week in most of these patients, but very very quickly.

Speaker Change: The test itself is drawn more or less when the patients come in and get there. Their first follow up scan after their sixth cycle of R. Chop. So this is a standard of care scan.

Speaker Change: Taken between three and say six weeks or so after that last dose of chemo.

Zachary Roberts: If the patient's in remission, that makes them potentially eligible for Alpha 3. They have their MRD test drawn. They get the result back in a week to two weeks, and if they're MRD positive, that patient would then potentially be eligible to come into the trial. So it all happens very, very quickly, and the likelihood of a patient relapsing in that interval is not zero, but it's actually quite low because most of those relapses do occur, say, at the time of the next scan, which may be two to three months later So we're hoping to get all this work done while the patients are still in remission so we can effectively deliver the consolidation dose of CT.

Zachary Roberts: If the patient's in remission, that makes them potentially eligible for Alpha 3. They have their MRD test drawn. They get the result back in a week to two weeks, and if they're MRD positive, that patient would then potentially be eligible to come into the trial. So it all happens very, very quickly, and the likelihood of a patient relapsing in that interval is quite low, but it's actually quite low because most of those relapses do occur, say, at the time of the next scan, which may be two to three months later So we're hoping to get all this work done while the patients are still in remission so we can effectively deliver the consolidation dose.

Speaker Change: The patients interim mission that makes them potentially eligible for <unk> Alfa three they have their Mardi test drawn they get the result back in a week to two weeks and if they are I am already positive that patient when they would then potentially be eligible to come into the trial.

David Chang: As the study progress a little bit more, you know, we will be able to provide some information of, you know, regards to, you know, the MRD positive rate and things like that, but right now it's purely to comment on that. The second one, the response is pretty easy with the ongoing studies, especially the Alpha 3 study, which is what the study that you are referring to. Yes, the clinical material for the Alpha 3 is coming from the CFL manufactured somehow.

Zachary Roberts: They have their MRD test drawn. They get the result back in a week to two weeks. And if they're MRD positive, that patient would then potentially be eligible to come into the trial. So it all happens very, very quickly. In the likelihood of a patient relapsing in that interval is non-zero, but it's actually quite low because most of those relapses do occur, say, you know, at the time of the next scan, which may be two to three months later.

Speaker Change: So it all happens very very quickly and the likelihood of a patient relapses in that interval is non non zero, but it's actually quite low.

Speaker Change: Because most of those relapses do occur at.

Speaker Change: At the time of the next scan, which may be two to three months later, so we're hoping to get all of this work done while the patients are still in remission. So we can effectively deliver the consolidation dose of <unk>.

Zachary Roberts: So we're hoping to get all this work done while the patients are still in remission so we can effectively deliver the consolidation dose of chemo. Thank you.

David Chang: Okay. And then maybe just curious on your thoughts around the, because we saw recently a relapse case with an autologous CD19 CAR T program out of ULAR back in June, just curious what your thoughts are on that data set. And do you have any, and does that have any impact on how you think about, you know, your dosing or lympho depletion regimen for three to nine. Thanks for taking our question. Yeah, so that's sort of an added question.

Reni Benjamin: Please stand by for our next question. Our next question comes from the line of Reni Benjamin, but Citizens' JMP, Yelena is open. Hey, good afternoon, guys. Thanks for taking the question and correct on all the progress.

Operator: Please stand by for our next question. Our next question comes from the line of Reni Benjamin with Citizens JMP. Your line is open. Hey, good afternoon.

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

Reni Benjamin: Hey, good afternoon, guys. Thanks for taking the question and congrats on all the progress. Just regarding ALO329, could you give us a sense as to when we might see some preclinical data and what we should be kind of focusing on? Because, correct me if I'm wrong, persistence doesn't seem to be one of the more important factors to focus on as compared to depth of depletion. But any feedback would be great on that. And, I guess, just as a follow up. Given there's some work with PCMA targeting agents in autoimmune diseases as well, is there a chance that aloe 715 might see a revival?

Reni Benjamin: Hey, good afternoon guys, thanks for taking the question and congrats on all the progress. Just regarding ALO329, could you give us a sense as to when we might see some preclinical data and what we should be kind of focusing on because, you know, correct me if I'm wrong, persistence doesn't seem to be one of the more important factors to focus on as compared to, you know, depth of depletion, but, you know, any feedback would be great on that. And I guess just as a follow-up. Given there's some work with PCMA targeting agents in autoimmune diseases as well, is there a chance that aloe 715 might see a revival?

Reni Benjamin: Hey, good afternoon, guys. Thanks for taking the question and congrats on all the progress.

Zachary Roberts: Just regarding all of 329, could you give us a sense of when we might see some pre-clinical data and what we should be kind of focusing on because, you know, correct me if I'm wrong, persistence doesn't seem to be, you know, kind of the more important factors to focus on is compared to, you know, depth of depletion, but, you know, any feedback would be great on that.

Reni Benjamin: Just regarding allo three to nine could you give us a sense as to when we might see some preclinical data.

Speaker Change: And what we should be kind of focusing on because correct me if I'm wrong persistence doesn't seem to be kind of the more important factor is to focus on as compared to depth of depletion but.

David Chang: I think, you know, that is referring to the autologous CD19 CAR T being studied autoimmune indications. You know, the way we view is that, you know, still there is a lot going on with the signal finding and, you know, the proof concept data being generated. As that happens, you know, there will be some variability. I don't think, you know, the recent findings that as reported at ULAR, it doesn't really change any assumptions around what the CAR T therapy can do in the autoimmune indications.

Speaker Change: Any feedback would be great on that and I guess, just as a follow up just given there is some work with <unk> targeting agents in autoimmune as well is there a chance that allo 715 might see a revival.

Zachary Roberts: And I guess just as a follow-up, just given there's some work with PCMA targeting agents in order to meet as well, is there a chance that ALO 715 might see a revival? Thanks.

Speaker Change: Sure.

Zachary Roberts: Hey, Reni, this is Zach here. So the first question on the pre-clinical data, we are hoping to share that soon. And, you know, there are related data from a somewhat related product that we shared last year at SITSI. So, for those of you who can't wait for the update with the 329 product, you can get a little bit of a preview from the data we shared last year. That is using the old gene editing platform, so we've made a few updates, but that will be a good appetizer for you as we are preparing that pre-clinical data for later this year.

Zachary Roberts: Hey, Reni. This is Zach here.

<unk>: Hey, Randy this is <unk> here. So the first question on the preclinical data we are hoping to share that soon.

David Chang: You know, what we are seeing, you know, fundamentally is very different than all out of treatment that has gone forward in the autoimmune indication. You know, specifically the, you know, potential of being able to provide long-term remission after a single infusion, that is very attractive. You know, the duration of long-term remission, I think that's what's coming into question and what is, you know, the length of remission that would really, you know, make us to get excited about.

Speaker Change: And.

Speaker Change: There are related data from a somewhat related product that we shared last year at 50. So.

Zachary Roberts: So the first question on the preclinical data, we are hoping to share that soon. And, you know, there are related data from a somewhat related product that we shared last year at CITSE. So for those of you who can't wait for the update with the 329 product, you can get a little bit of a preview from the data we shared last year, but that is using the old gene editing platform. So we've made a few updates, but that will be a good appetizer for you as we are preparing that preclinical data for later this year.

Speaker Change: For those of you who can't wait for the update with the 302 nine product you can get a little bit of a preview from the data. We shared last year that is using the old gene editing platform. So we've made a few updates but.

Speaker Change: That is will be a good appetizer.

Speaker Change: For you is we are preparing that preclinical data.

Speaker Change: Data for later this year.

Zachary Roberts: As far as the question around persistence, you know, obviously that's very hard to measure outside of a clinical trial, but I would agree with the premise of the question that, you know, our belief, which is built on the data that's been shared from the autologous field, as well as that paper that was alluded to previously in the alo carte, is that it's likely that the persistence is going to have to be shorter here, or Finally, your question around BCMA and 715. We currently do not have any plans to put 715 into the clinic for the treatment of autoimmune diseases, but of course, we'll be watching that field very carefully in the coming months.

Zachary Roberts: As far as the question around persistence, you know, obviously, that's very hard to measure outside of a clinical trial, but I would agree with the premise of the question that, you know, our belief, which is built on the data that's been shared from the autologous field, as well as that paper that was alluded to previously in the AlloCartee, is that it's likely that the persistence is going to have to be Finally, your question around BCMA and 715. We currently do not have any plans to put 715 into the clinic for the treatment of autoimmune diseases, but of course, we'll be watching that field very carefully in the coming months.

Zachary Roberts: As far as the question around persistence, you know, obviously that's very hard to measure outside of a clinical trial. But I would agree with the premise of the question that, you know, our belief, which is built on the data that's been shared from the autologous field, as well as that paper that was alluded to previously in the ALO CART, is that it's likely that the persistence is going to have to be shorter here or could be shorter than it does need to be in oncology, which we think bodes well for allogeneic products like ALO 329.

David Chang: I think that, you know, is something that we are following closely, but most of the patients who have been treated with the autologous CD19 CAR T. And also with some of their, you know, BCMA CAR T, what we are seeing is that the durability of response is very good lasting a year longer and sometimes ongoing response as the last data, you know, cuts. So it really doesn't change any of the assumptions that we are making with our allotry tonight, which as an allotry CAR T provides a lot more benefit that will be important as we think about the autoimmune indications.

Speaker Change: As far as.

Speaker Change: The question around persistence.

Speaker Change: Obviously that is very hard to measure outside of a clinical trial.

Operator: Thank you. Please stand by for our next question.

Speaker Change: But I would agree with the premise of the question that are our belief, which is built on the data that's been shared from the autologous field as well as that paper that was alluded to previously on the in the Allo car T is that it's likely that the persistence is going to have to be shorter here or could be shorter than it does.

Speaker Change: We need to be in oncology, which we think bodes well for allogeneic products like Alan <unk>.

Zachary Roberts: Finally, your question around BCMA and 715. We currently do not have any plans to put 715 into the clinic for treatment of autoimmune disease. But of course, we'll be watching that field very carefully in the coming months and years.

Speaker Change: Finally, your question around <unk> and $7 five we currently do not have any plans to put seven five into the clinic for treatment of autoimmune disease, but of course, we'll be watching.

Michael Yee: Our next question comes from the line of Michael Yee with Geoffrey, Cielan is open. Hi, thanks for taking our questions.

Speaker Change: That feel very carefully in the coming months and years.

Operator: Thank you. Please send them by for our next question.

Operator: Please stand by for our next question. Our next question comes from the line of Byron Amin with Piper Sandler. Your line is open. Yeah. Hi guys.

Operator: Please stand by for our next question. Our next question comes from the line of Biren Amin with Piper Sandler. Your line is open. Yeah. Hi guys.

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

Erin: Our next question comes from a line of bar and omen with Pythasandler. Yelana is open. Yeah, hi guys. Thanks for taking my questions. Maybe to start on the CLL program. I noticed the slight pushout on data from year end this year to early next year. Are we still, I guess, expecting 12 patients with the data, and should the comp be, you know, the brown Z 20% CRA? Is that, I guess, what we should be looking towards when we receive the data?

Speaker Change: Our next question comes from the line of Byron I mean with Piper Sandler Your line is open.

Speaker Change: Yeah, Hi, guys. Thanks for taking my question. So maybe to start on the CLO program I noticed a slight push out on data from year end. This year to early next year are we still I guess expecting 12 patients worth of data and should the comp be beyond the 20% CRE is that I guess, what we should be looking towards that.

Zachary Roberts: Hi, this is Zach, so great question. And so the approach that we are taking is, I would say, both similar and distinct from what we've taken in the later line studies that we've had ongoing for a few years at Allogene. As you rightly point out in your question, the target population that we are pursuing in Alpha 3 for the most part are treated in the community. There are some patients who do get treated at large academic centers, either from the outset or through referral.

Speaker Change: When we receive the data.

David Chang: Hi, Erin.

Biren Amin: Hi Biren, let me take on the first question. With your eagle eyes, I guess you noticed that we have pushed out the timeline a little bit. That really comes from the fact that, in the current environment, we have the need to prioritize and focus on the Alpha 3 study. That is our primary interest in rolling into the study and monitoring how that study advances. It's really a reflection of the reallocation of internal resources to support the Alpha 3 study, which so far is progressing extremely well.

David Chang: Hi Buren. Let me take on the first question. With your eagle eyes, I guess you noticed that we have pushed out the timeline a little bit. That really comes from the fact that, in the current environment, we have the need to prioritize and focus on the Alpha 3 study. That is our primary interest in rolling into the study and monitoring how that study advances. So it's really a reflection of the reallocation of internal resources to support the Alpha 3 study, which so far is progressing extremely well.

David Chang: Let me take on the, you know, first question. You know, would you eagle eyes? I guess you noticed that we have pushed out the timeline a little bit. That really comes from the fact that in the current environment, we have the need to prioritize and focus on the upper three study. That is our primary interest in rolling into the study and monitoring how that study advances. So, you know, it's really a reflection of, you know, reallocation of internal resource to, you know, support the offer three study, you know, which so far is, you know, progressing extremely well.

Speaker Change: Erinn, let me take on the first question.

Speaker Change: Eagle Eyes, I guess thing you'll notice that we have pushed out the timeline a little bit that really comes from the fact that in the current environment, we have the need to prioritize and focus on the <unk> III study that is our primary interest enrolling into the study and monitoring how that study advances so.

Speaker Change: It's really a reflection of we are.

Speaker Change: Allocation of internal resource to.

Zachary Roberts: But up to about 80% of patients with frontline are newly diagnosed, LDCL are treated in the community. That fact alone has really guided our decision making around site selection. And so as we mentioned in the prepare remarks and is reflected on clinical trial.gov, the early wave of studies that have activated sites that have activated in this study have indeed been community centers, which are the common centers for frontline care. That said, the large academic referral centers are always going to have a role to play in clinical trial execution.

David Chang: For that reason, we do not want to burden the team by asking them to also accelerate the CLL study. Our target for the Phase 1 study in CLL has not changed. It's essentially targeting approximately 12 patients for enrollment. And the bar that we are aiming for is, as we have previously communicated, set by what we have seen with Brionzi in relapse-refractory CLL patients.

Speaker Change: Support for three study, which so far is <unk>.

David Chang: And, you know, and for that reason, you know, we did not want to burden the team by, you know, asking, you know, them to also accelerate the CLL study. You know, our target for the phase one study, you know, for the, in the CLL has not changed. It's essentially targeting approximately 12 patients in moment. And the bar that we are aiming for is, as we have previously communicated, set by what we have seen, you know, with the reality in the real estate refractory CLL patients.

Speaker Change: Pressing extremely well and.

Biren Amin: For that reason, we do not want to burden the team by asking them to also accelerate the CLL study. Our target for the Phase 1 study in CLL has not changed. It's essentially targeting approximately 12 patients for enrollment. The bar that we are aiming for is, as we have previously communicated, set by what we have seen with Brionzi in relapse-refractory CLL patients.

Speaker Change: And for that reason, we do not want to burden the team by.

Speaker Change: Asking them to also accelerate the CLI study.

Speaker Change: Target for the Phase one study.

Speaker Change: Cielo has not changed essentially.

Speaker Change: Targeting approximately 12 patients enrollment and the bar that we are aiming for is as we have previously communicated a set by what we have seen.

Speaker Change: With the P&C in the relapse refractory CLO patients.

Zachary Roberts: And so as those that list grows on clinical trials.gov, you'll see some familiar faces with partners that we have had for a long time. And also say that we've expanded our reach into some academic centers that have not opened up study before. So we are actually pretty excited about the breadth and the variation in the types of sites, both old and new community and academic as we're getting this study up and running. Thank you.

William Pickering: Please stand by for our next question. Our next question comes from the line of William Pickering with Bernstein. The line is open. Hi, good afternoon. Thank you for taking my question. Congrats on all the progress, especially the activation of the community sites in Alpha 3. What are some of the attributes of community sites that seem to be making them more or less interested in participating in the study? Is it about infrastructure, prior clinician experience with CARTI, or some other fact, or just trying to get a sense for how to sub-segment this community setting given that it represents such a large percentage of patients?

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

David Chang: Thank you. Please stand by for our next question. Our next question comes from the line of William Pickering with Bernstein. Your line is open. Hi, good afternoon. Thank you for taking my question. Congratulations on all.

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

William <unk>: Our next question comes from the line of William <unk> with Bernstein. Your line is open.

William: Hi, Good afternoon. Thank you for taking my question Congrats on all the progress, especially the activation of community sites in Alpha three.

William: What are some of the attributes of community sites that seem to be making them more or less interested in participating in the study is it about infrastructure prior clinician experience with car T or some other factor.

Tyler Van Buren: Please stand by for our next question. Next question comes from the line of Tyler Van Buren with TV Cohen, you're on it's open. Hey guys, good evening, congratulations on all the progress.

Speaker Change: I'm, just trying to get a sense for how to sub segment. This community setting given that it represents such a large percentage of patients. Thank you.

Zachary Roberts: Thank you.

Zachary Roberts: So if enrollment for alpha three is expected to complete during the first half of 2026, you will elaborate on what the interim EFS analysis during the first half of 2026 is expected to look like in what it's specific purposes and why you need it just ahead of the final EFS analysis. Hey Tyler, Zach, thanks for the question. So, you know, as we mentioned, we've modeled out and we've discussed on in this venue before we've modeled out what the expected time to event is EFS in this case for patients who are in the observation arm and it's quite short.

Zachary Roberts: Hey, William, this is Zach. So, excellent question. And, you know, let's sort of help you parse that out. So I think, first and foremost, the single that we're hearing loudest and clearest from our community partners is that they are really excited to be able to offer CARTI to their patient population. And, as I said, most of these community centers don't currently do that. They have to refer their patients out when they relapse. So, as I mentioned before, you have to have a clinical relapse in order to be eligible for all approved CARTI. And if those community centers do not offer CARTI, that means that those patients have to be referred out.

William Pickering: Hey, William, and Zach, excellent question. And, you know, let's sort of help you parse that out. So I think, first and foremost, the signal that we're hearing loudest and clearest from our community partners is that they are really excited to be able to offer CAR T to their patient population. And as I said, most of these community centers don't currently do that. They have to refer their patients out when they re

Zachary Roberts: Hey, William, this is Zach. So an excellent question. And, you know, let's sort of help you parse that out. So I think, first and foremost, the signal that we're hearing loudest and clearest from our community partners is that they are really excited to be able to offer CAR T to their patient population. And, as I said, most of these community centers don't currently do that. They have to refer their patients out when they relapse.

Speaker Change: Okay.

Zack: Hey, William Zack So excellent question and.

Speaker Change: Let's sort of help you parse that out so I think.

Speaker Change: First and foremost the signal that we are hearing loud and clear from our community partners is that they are really excited to be able to offer car T to their patient population and.

Speaker Change: As I said most of these community centers don't currently do that they have to refer their patients out when they relapse. So.

Zachary Roberts: So, as I mentioned before, you have to have a clinical relapse in order to be eligible for all approved CAR-T. And if those community centers do not offer CAR-T, that means that those patients have to be referred out. And oftentimes, those patients don't want to be referred. They will accept a non-CAR-T option for salvage therapy if that allows them to stay with the doctor that they've come to trust and in the center that is close to their home.

William Pickering: So, as I mentioned before, you have to have a clinical relapse in order to be eligible for all approved CAR-T. And if those community centers do not offer CAR-T, that means that those patients have to be referred out. And oftentimes, those patients don't want to be referred. They will accept a non-CAR-T option for salvage therapy if that allows them to stay with the doctor that they've come to trust and in the center that is close to their home.

Speaker Change: I've mentioned before you have to have a clinical relapse in order to be eligible for all approved.

Zachary Roberts: I mean, the prognosis of these patients with MRD positive disease at the end of our chop is poor and the time to progression is measured in weeks to months. So that's given us the opportunity to perform this interim analysis and we haven't gone into details around what the volume or the percentage of the data that we will be examining of that interim analysis is. But it will allow us to potentially initiate conversations with FDA.

Zack: And if those community centers do not offer car T that means that those patients have to be referred out and oftentimes those patients don't want to be referred they will accept a non car T option for salvage therapy, if that allows them to stay with the doctor that they've come to trust and in the center that is close to their home.

Zachary Roberts: And oftentimes, those patients don't want to be referred. They will accept a non-CARTI option for salvage therapy if that allows them to stay with the doctor that they've come to trust and in the center that is close to their home. As to why these community centers have not begun to offer autologous programs, the reasons there are varied. But, to one degree or another, they all come down to the investment that would be required by these centers to build out the infrastructure in terms of specialized team members, a ferrisis capacity, and potentially even inpatient management facilities to actually offer these products safely to patients.

Zachary Roberts: As to why these community centers have not begun to offer autologous programs, the reasons are varied. But to one degree or another, they all come down to the investment that would be required by these centers to build out the infrastructure in terms of specialized team members, apheresis capacity, and potentially even inpatient management facilities to actually offer these products safely to patients. So we really believe that we have threaded this needle here and are offering an off-the-shelf option to patients who are in need and who likely could derive a significant benefit while all being able to be done at the centers where they are most comfortable, and they get to stick with their doctor.

William Pickering: As to why these community centers have not begun to offer autologous programs, the reasons are varied. But to one degree or another, they all come down to the investment that would be required by these centers to build out the infrastructure in terms of specialized team members, apheresis capacity, and potentially even inpatient management facilities to actually offer these products safely to patients. So we really believe that we have threaded this needle here and are offering an off-the-shelf option to patients who are in need and who likely could derive a significant benefit while all being able to be done at the centers where they are most comfortable, and they get to stick with their doctor.

Speaker Change: As to why these community centers have not.

Speaker Change: <unk> begun to offer autologous programs. The reasons there are varied but to one degree or another they all come down to the investment that would be required by these centers to to build build out the infrastructure in terms of.

Zachary Roberts: It will also allow us to get a sense of, you know, what the potential market penetration could be. So there are a lot of quite significant practical benefits to having an early formal look at that data that will certainly guide us in the direction of what we expect for the primary as well. So all those balls will be able to begin rolling in the first half of 2026. That's our vision. Thank you.

Speaker Change: Specialized team members <unk> capacity and potentially even in patient management facilities to actually offer. These these products safely.

Zachary Roberts: So, we really believe that we have threaded this needle here and are offering an off-the-shelf option to patients who are in need, and who likely could derive a significant benefit, while all being able to be done at the centers where they are most comfortable and they get to stick with their doctor. Thank you.

Speaker Change: Two patients. So we really believe that we have thread. This needle here in our offering an off the shelf option to patients who are who are in need and who likely could derive significant benefit while all being able to fit to be done at the centers, where they are most comfortable in there and they get to stick with their doctor.

Jack Allen: Please stand by for our next question. Our next question comes from the line of Jack Allen with Bear. Your line is open. Great. Thanks so much for taking the questions and congratulations on the progress made over the quarter. I just wanted to ask a couple here.

David Chang: The first which is on the manufacturing process update. It sounds like all the product is now coming from self-words one. I just wanted to ask if you have any sense for any differences in potent. So you as it relates to self-words one manufactured products as compared to CMO products. Were there any changes in the process there? Is it still the alloy process that you are utilizing at both centers?

Zachary Roberts: Thank you. 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 closing remarks.

Operator: Ladies and gentlemen, I'm sure no further questions in the queue.

Operator: Thank you. 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 closing remarks.

Speaker Change: Thank you, 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 closing remarks.

David Chang: I would now like to turn the call back over to management for closing remarks. Yeah, I'd like to thank you all of you on the call for your interest and continued support as we progress on our industry-leading programs. Last quarter and going forward, it will be all about the momentum. You know, we are more energized than ever with the path forward and the building momentum that we believe will lead to sustained growth.

David Chang: Yeah, I'd like to thank all of you on the call for your interest and continued support as we progress on our industry-leading programs. Last quarter and going forward, it will be all about the momentum. You know, we are more energized than ever with the path forward and the building momentum that we believe will lead to sustained growth. Operator, thank you, and you may now disconnect.

Speaker Change: Yes, I'd like to thank you all of you on the call.

Speaker Change: Our interest and continued support as we progress on our industry leading programs.

Zachary Roberts: And then really briefly on CLL, I was hoping you could provide some context as to what we should look for in early 25. We'd love to hear about the size and breadth of that data set that we should expect in the early next year. Hi, Jack. Thanks for the questions.

Speaker Change: Last quarter and going forward it will be all about the momentum we are more energized than ever with a path forward and the building momentum that we believe will lead to sustained growth.

Operator: So, operator, thank you, and you may now disconnect.

Speaker Change: Thank you and you may now disconnect.

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

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect. Thank you very much.

David Chang: Let me take the manufacturing questions and I will defer the CLL question to Zach in terms of in a manufacturing. We have successfully manufactured all the products that we are currently investigating in the clinics at CF1. With respect to the details of how we are characterizing, we have a very high standard of characterizing the products that includes the potency. The way that we characterize the potency is looking at both what's required for the release of the product as well as the characterization that we use for the internal learning and for the improvement as we work on the processes. You know, it can really go too much into that, but so far the products that we are manufacturing at CF1 is meeting all the standard out to take it into the clinics.

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

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Okay.

Zachary Roberts: And Jack, I can address your question on CLL. So, you know, we are obviously importing most of our efforts and attention into the alpha 3 program and CLL continues to run alongside. And so, as we look towards that data update and in the early 2025, again, I would say, you set the expectations roughly around the same target number of patients with as much follow up as we can generate. Thank you.

Lana Astica: Please stand by for our next question. Our next question comes from Lana Astica, Gone Wardening, which is true with Yelana's open.

David Chang: Hi, guys. Good evening, and thanks for taking my questions and I forgot to get a note as well on the progress. On, I want 3 to 9, the potential to reduce or eliminate limitation is obviously very attractive, but it might be also important to distinguish between those two words. So, here's to know how many patients do you think you'll need to treat with 3 to 9 to actually figure that out. And do you think we might have an answer to that in 2025 from your first treat out on the study?

David Chang: Astica, this is David. Let me take on that question. You know, what you are asking is a very important question, but I think it's too early to sort of, you know, layout, you know, what, how we are thinking about the lymphatic lesion. It is, it will be, you know, one of the primary focus about phase one, you know, exploring the different lymphatic lesion as well as looking the ways to reduce the, you know, the lymphatic lesion that's currently being used in the hotel city, 19 car, tea, trials, you know, the immune.

David Chang: But what we know from the 3 to 9, you know, with a dual city, 19 city, 70 approach, we do have many different options that are available in the study design to test, you know, the, this important question. Thank you. Please stand by for our next question.

Brooke Gray: Our next question comes from the line of Sammy Coleman with William Blair, Yalena Sopin. Hi, thank you for taking our question. This is Brooke Schuster on for Sammy.

Zachary Roberts: So regarding the community centers, given that these centers are less likely to be less experienced or have no CAR-T experience, are they getting extra training to be prepared for CAR-T treatment such as recognizing safety signals and ensuring proper MRD testing, et cetera. Hey, Brooke, this is Zach. Thank you for the question. So we approach every site, kind of with the same view in mind, and that is, you know, we want to make sure that they have all the tools and the information they need to safely manage their patients.

Zachary Roberts: So for the large academic centers that have been doing CAR for 10 plus years, they would need potentially a little bit less training, although we still do offer that training than somebody who has somewhat less experience or maybe even no experience at all. We feel like we're in a pretty good place starting out because our safety profile for semicell, as we've shown in our phase one study, is actually fairly well tolerated with varied little, in fact, no high-grade CRS or ICANNs, sort of an infection profile that is very consistent with patients who are receiving treatment for various different types of cancer.

Zachary Roberts: So these are not truly naive centers. They stocked hostelism ab in their pharmacies, et cetera. So we actually feel like this should be fairly manageable, but it's a good question and we are making sure that each center is fully trained to handle this safely.

Zachary Roberts: You also asked about collection of the MRD tests. So I'm proud to say that this is actually a fairly straightforward test that these sites will have to collect. In fact, it's very similar in terms of what they have to do on their side to just about any other test that is collected now for lung cancer, breast cancer. There's a piece of tumor that is sent in and then a blood test and then foresight handles the rest. So that should hopefully have very few errors or any difficulties. Thank you.

Matthew Biegler: Please stand by for our next question. Our next question comes from the line of Matthew Beegler with Oppenheimer. Yaline is open. Hey guys, thanks for a question. It's great to be back.

David Chang: Wanted to your opinion on the importance of T cells and contributing to certain autoimmune diseases. It seems, you know, obviously like an industry where singularly focused on the B cell reset, but I guess, you know, with some of the data mentioned that you are on relapse as I'm just curious. You know, it seems like your dagger technology not only can maybe do away with limpo conditioning, but also target reactive T-cells. So just kind of curious, like if you think you might have an edge on other players in the autoimmune space. Thanks.

David Chang: Hey, Matthew, great to have you back. And you know, very important question as we think about the Carties in autoimmune space. I mean, you know, I think we have to start, you know, design of the product. You know, thinking about this disease from the fundamental biologic perspective, you know, autoimmune disease is never a disease of in a B-cells. It's always in a D-B-cells and contributing T-cells that really, you know, eventually manifest the symptoms of autoimmune diseases.

David Chang: So from that perspective, we felt being able to target activated T-cells. And we achieved that by going after C-cells. So in the D-70, which I expressed on the activated T-cells, we believe that this is very important to maximize the, you know, potential of all three to nine across different autoimmune education. So yes, we have to show it in a clinical data, but it definitely increases the potential of all three to nine versus, you know, car key programs that are simply targeting B-cells. Thank you.

David Chang: Please stand by for our next question. Our next question comes from the line of John Newman with Canacor, Yalena Sullivan. Hi guys, congrats on the progress and thanks for taking my question. So David, we've seen some data recently from two targets, Cartie programs in the autoimmune setting, which I'm sure everybody on the call is very familiar with. My question is, is there something different beyond the targeting of active T-cells for all three to nine, for example, manufacturing or another aspect that you think could result in more consistent results when you run the study.

David Chang: I think we're all trying to figure out exactly what the autologist data mean, but what I'm curious about is, is there something specific perhaps in the manufacturing process or somewhere else for three to nine that could give more consistent results in the future. Thanks.

David Chang: Hi John, thanks for that excellent question. I mean, the manufacturing at the end is one of the big differences that can result in the difference in the outcome. We don't have all the details of, you know, how different programs that have taken City 19 Cartie into the autoimmune space, you know, have been manufactured, but definitely, you know, we do strongly believe that how the cells are prepared, you know, what do the cells frozen before administration or administered without freezing all these things together with, you know, the way that the cells are being treated.

David Chang: It's like expanded, you know, makes a big difference. Unfortunately, the details are somewhat lacking because the information, some are kept as a proprietary information, but I think that is a very important question as for the in a three to nine. You know, we have taken a different approach of manufacturing, you know, fundamentally, how we introduced the trans chain that expressed our car, whether we do lentifiers, we have in this case taken the path of doing such specific integration using CRISPR based a nucleus and AAB.

David Chang: And you know, study section on that kind of approach can potentially improve the consistency of the final product, which we believe is very important as we think about indication such as autoimmune. So stay tuned. Thank you.

Zachary Roberts: Please stand by for our next question. Our next question comes from the line of Ben Burnett with Steve Fulk. Your line is open. Hey, thank you very much. I also wanted to ask about all of 329 and other immune disease. There's a recent disclosure with a CD-19 Allogeneic CAR-T from BRL medicine. It was via an academic study in China, but without the data look quite good. That BRL asset though, it contained a number of edits and modifications.

Zachary Roberts: So I guess the question is number one, it would be great to get your thoughts on those data. And just secondly, I guess how does the technology that you're implementing and with all of 329 would dagger and everything else sort of compare to that BRL asset. Then this is that.

Zachary Roberts: Thanks, very insightful question. And thanks for bringing up that exciting report. So we share I think the enthusiasm around that first report of responses to a CD-19 Allogeneic CAR-T in three patients with two different autoimmune indications. We feel that that is a very strong proof of concept that this platform, which we have demonstrated is functional and oncology is likely to also be operable in autoimmune disorders. You rightly highlight some of the strategies that they have employed to ensure adequate expansion and persistence.

Zachary Roberts: They have taken what might be called a sort of a cloaking strategy where they've eliminated MHC molecules and they've also disrupted the PD-1 axis. This is a strategy that has been tried by others. And I think that it's probably still too early to say whether that is globally speaking a successful path. Our plan, it has relied on the dagger technology to ensure that we do get that adequate expansion and persistence. And we feel very comfortable that this sort of dagger versus the cloaking strategy will deliver benefits.

Zachary Roberts: And we've seen this now in the RCC program with the ALO-316 product where we get up to two logs, better expansion and improved persistence, even with the de-intensified lymphotoclesian regimens. So I think every Allogeneic platform is going to have to deal with the idea of premature rejection. And we are very confident that the dagger is going to give us a path forward there. Thank you.

David Chang: Please stand by for our next question. Our next question comes from the line of Luca is he with RBC capital. Yalan is open. Oh, great. Thanks so much for a thing. My question is congrats on the progress. Maybe just a quick one, David or Zach on what's the latest thinking of whether you think that anti-CD-52 was actually needed as part of the lymphotoclesian in ALO-3? I was always under the impression that adding CD-52 was actually important to discriminate between endogenous and exogenous T-cells.

David Chang: But it feels to me that you're maybe downplaying that little bit recently. And maybe you're now thinking that anti-CD-52 may not be needed as part of the pletion. What am I right? And if so, how should we think about the overall profile of your drug in a scenario where anti-CD-52 is needed versus not needed? Any thoughts there? Much appreciated. Thank you.

David Chang: That's why, you know, we feel that, you know, testing the length of the patient both with and without the CD-52 anybody or L-647 that we are using is an important scientific question. And also, you know, by doing the study as we have designed alpha-3, it gives us a really an opportunity to carefully review and dissect the contribution of 647 for as a limb for depletion in the MRD in a setting. So, that's a question that is to be, you know, tested and, you know, either case in alpha-3 study, you know, we are counting on the, you know, outcome as measured by the EFS. And whether we proceed with FC or FCA doesn't really change in what we are trying to do with alpha-3 study. Thank you.

Operator: Well, you stand by for our next question.

Tony Butler: Our next question comes from the line of Tony Butler with Rodman and Rinshaw.

Zachary Roberts: Your line is open. Hi. This is Tosh, the son on for Tony. David, and that you briefly touched upon this, the, the embedded testing for patients and, you know, I'm assuming that this is done very soon after the patient is done with the 6th cycle of chemotherapy. Now, I wonder if you could flesh out, flesh this out a little bit, for example, you're given that, you know, sometimes this is comes back rather quickly for MRD publications. How long it takes for patients to get the results and additionally is whether the test is something easy or does the patient need to go to a specialized facility to be tested.

Zachary Roberts: Thank you. Hi there. This is Zach. So you absolutely spot on. This is a race against time to, to make sure that we can get the dose of semicell in while the patients are still in remission. And in fact, we think that that speed is actually what makes an allocarty product that's suited for this type of a trial as to the specifics. So first, the patients will get their MRD tests at the centers where the study will be open.

Zachary Roberts: So there's no need to go to a specialized place to get the blood drawn. All of that will be collected just as any other clinical trial bio specimen is collected every day in other trials. And that has been sent in to Forsyth who runs the test. That test is, we will have that result back within one to two weeks, hopefully closer to one week in most of these patients, but very, very quickly.

Zachary Roberts: The test itself is drawn more or less when the patients come in and get their, their first follow-up scan after their sixth cycle of our job. So this is a standard of care scan taken between three and say six weeks or so after that last dose of chemo. If the patient's in a remission, that makes them potentially eligible for alpha three. They have their MRD test drawn. They get the result back in a week to two weeks.

Zachary Roberts: And if they're MRD positive, that patient would then potentially be eligible to come into the trial. So it all happens very, very quickly in the likelihood of a patient relapsing in that interval is non-zero, but it's actually quite low because most of those relapses do occur say, you know, at the time of the next scan, which may be two to three months later. So we're hoping to get all this work done while the patients are still in remission so we can effectively deliver the consolidation dose of chemo.

Zachary Roberts: Thank you.

Operator: Please stand by for our next question.

Reni Benjamin: Our next question comes from the line of Reni Benjamin, but Citizens' JMP, Yelena is open. Hey, good afternoon guys. Thanks for taking the question and correct on all the progress.

Zachary Roberts: Thanks. Hey, Reni, this is Zach here. So the first question on the pre-clinical data, we are hoping to share that soon. And, you know, there are related data from a somewhat related product that we shared last year at SITSI. So for those of you who can't wait for the update with the 329 product, you can get a little bit of a preview from the data we shared last year. That is using the old gene editing platform so we've made a few updates, but that will be a good appetizer for you as we are preparing that pre-clinical data for later this year.

Erin: Our next question comes from a line of bar and omen with pythasandler. Yelana is open. Yeah, hi guys. Thanks for taking my questions. Maybe to start on the CLL program. I noticed the slight pushout on data from year end this year to early next year. Are we still, I guess, expecting 12 patients with the data and should the comp be, you know, the brown Z 20% CRA is that I guess what we should be looking towards when we receive the data? Hi, Erin.

David Chang: And, you know, and for that reason, you know, we did not want to burden the team by, you know, asking, you know, them to also accelerate the CLL study. You know, our target for the phase one study, you know, for the, in the CLL has not changed. It's essentially targeting approximately 12 patients in moment. And the bar that we are aiming for is as we have previously communicated is set by what we have seen, you know, with the reality in the real estate refractory CLL patients.

William Pickering: Please stand by for our next question. Our next question comes from the line of William Pickering with Bernstein. The line is open.

Zachary Roberts: Hi, good afternoon. Thank you for taking my question. Congrats on all the progress, especially the activation of the community sites in Alpha 3. What are some of the attributes of community sites that seem to be making them more or less interested in participating in the study? Is it about infrastructure, prior clinician experience with CARTI or some other fact or just trying to get a sense for how to sub-segment this community setting given that it represents such a large percentage of patients?

Zachary Roberts: Thank you. Hey, William, this is Zach. So, excellent question. And, you know, let's sort of help you parse that out. So I think, first and foremost, the single that we're hearing loudest and clearest from our community partners is that they are really excited to be able to offer CARTI to their patient population. And, as I said, most of these community centers don't currently do that. They have to refer their patients out when they relapse.

Zachary Roberts: So, as I mentioned before, you have to have a clinical relapse in order to be eligible for all approved CARTI. And if those community centers do not offer CARTI, that means that those patients have to be referred out. And oftentimes, those patients don't want to be referred. They will accept a non- CARTI option for salvage therapy if that allows them to stay with the doctor that they've come to trust and in the center that is close to their home.

Zachary Roberts: As to why these community centers have not begun to offer autologous programs, the reasons there are varied. But, to one degree or another, they all come down to the investment that would be required by these centers to build out the infrastructure in terms of specialized team members, a ferrisis capacity, and potentially even inpatient management facilities to actually offer these products safely to patients. So, we really believe that we have threaded this needle here and are offering an off-the-shelf option to patients who are in need, and who likely could derive a significant benefit while all being able to be done at the centers where they are most comfortable and they get to stick with their doctor. Thank you. Ladies and gentlemen, I'm sure no further questions in the queue.

David Chang: I would now like to turn the call back over to management for closing remarks. Yeah, I'd like to thank you all of you on the call for your interest and continued support as we progress on our industry leading programs. Last quarter and going forward, it will be all about the momentum. You know, we are more energized than ever with the path forward and the building momentum that we believe will lead to sustained growth.

Operator: So, operator, thank you and you may now disconnect.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation.

Operator: You may now disconnect. Thank you very much.

Q2 2024 Allogene Therapeutics Inc Earnings Call

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