Q3 2020 Autolus Therapeutics PLC Earnings Call

Investor Relations. Please go ahead.

Thank you Crystal.

Operator: Thank you, Crystal. Good morning or good afternoon, everyone.

Good morning, or good afternoon, everyone and thank you could take you called out in today's call on the financial results and operational highlights for the second quarter Twentytwenty.

Lucinda Crabtree: And thank you for taking part in today's call on the financial results and operational highlights for the second quarter of 2020. I am Lucinda Crabtree, Vice President of Investor Relations. With me today are Dr. Christian Itin, our Chairman and Chief Executive Officer, and Andrew Oakley, our Chief Financial Officer. Before we begin, I would like to remind you that during this call, we will be making forward-looking statements. All statements, other than statements of historical facts contained in this presentation, are forward-looking statements. Our actual results, performance, or achievements may be materially different from those expressed or implied by such forward-looking statements.

I only Cindy Crabtree, Vice President Investor Relations.

With me today auto to Christian Eitan, our chairman and Chief Executive Officer, and Andrew Oakley, Our Chief Financial Officer.

Before we begin I would like to remind you that during the school, we will be making forward looking statements.

All statements other than statements of historical facts contained in this presentation are forward looking statements.

Our actual results performance or achievements may be materially different from those expressed or implied by such forward looking statements.

Lucinda Crabtree: For a discussion of the risks and uncertainties relating to our business and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, please see the section titled Risk Factors in our Annual Report on Form 20-F filed on March 3rd, 2020, as amended, as well as discussions of potential risks and uncertainties and other important factors in our other periodic filings with the SEC. The forward-looking statements contained in this presentation reflect the company's views as of the date of this presentation regarding future events, and the company does not assume any obligation to update any forward-looking statements. You should therefore not rely on these forward-looking statements as representing the company's views as of any date subsequent to the date of this presentation.

For a discussion of the risks and uncertainties relating to our business and other important factors any of which could cause our actual results to differ from those contained in the forward looking statements. Please see the section titled Risk factors and our annual report on form 20-F filed on March that Twentytwenty as amended as well as discussions of potential risks.

I am uncertainties and other important factors in our other periodic filings with the SEC.

The forward looking statements contained in the street in his presentation reflect the company fees as of the date of this presentation regarding future events.

The company does not assume any obligation to update any forward looking statements you should that go not rely on these forward looking statements as representing the company fees as of any date subsequent to the date of this presentation.

On slide three agenda, you'll see the agenda for today and it is as follows.

Operator: On slide three, Agenda, you'll see the agenda for today, and it is as follows: Christian will provide a brief introduction, and that will be followed by our operational highlights for the second quarter of 2020. Hello, ladies and gentlemen, and welcome to the Autolus Therapeutics second quarter 2020 financial results conference. As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Lucinda Crabtree, Vice President, Investor Relations. Thank you, Crystal.

Christian will provide a brief instruction and that will be followed by our operational highlights for the second quarter.

Hello, ladies and gentlemen, and welcome to the auto less Therapeutics second quarter 2020 financial results Conference call. As a reminder, this conference call is being recorded I would now like to turn the conference over to your hosts Dr., Cindy Crabtree Vice President Investor Relations. Please go ahead.

Ed.

Thank you Crystal good morning, or good afternoon, everyone and thank you for taking part in today's call on the financial results and operational highlights for the second quarter Twentytwenty.

Lucinda Crabtree: Good morning or good afternoon, everyone, and thank you for taking part in today's call on the financial results and operational highlights for the second quarter of 2020. I am Lucinda Crabtree, Vice President of Investor Relations. With me today are Dr. Christian Itin, our Chairman and Chief Executive Officer, and Andrew Oakley, our Chief Financial Officer. Before we begin, I would like to remind you that during this call, we will be making forward-looking statements. All statements, other than statements of historical facts contained in this presentation, are forward-looking statements. Our actual results, performance, or achievements may be materially different from those expressed or implied by such forward-looking statements.

I only Cindy Crabtree, Vice President Investor Relations.

With me today auto to Cushing, heighten, our chairman and Chief Executive Officer, and Andrew Oakley, Our Chief Financial Officer.

Before we begin I would like to remind you that during this call we will be making forward looking statements.

All statements other than statements of historical facts contained in this presentation are forward looking statements.

Our actual results performance or achievements may be materially different from those expressed or implied by the forward looking statements.

Lucinda Crabtree: For a discussion of the risks and uncertainties relating to our business and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, please see the section titled risk factors in our annual report on form 20 F filed on March 3rd, 2020, as amended, as well as discussions of potential risks and uncertainties and other important factors in our other periodic filings with the SEC. The forward-looking statements contained in this presentation reflect the company's views as of the date of this presentation regarding future events, and the company does not assume any obligation to update any forward-looking statements. You should therefore not rely on these forward-looking statements as representing the company's views as of any date subsequent to the date of this presentation.

For a discussion of the risks and uncertainties relating to our business and other important factors any of which could cause our actual results to differ from those contained in the forward looking statements. Please see the section titled Risk factors and our annual report on form 20-F filed on March the Twentytwenty as amended as well as discussions of potential risks.

Uncertainties and other important factors in our other periodic filings with the SEC.

The forward looking statements contained in this in this presentation reflect the company fees as of the date of this presentation regarding future events.

The company does not assume any obligation to update any forward looking statements you should that go not rely on these forward looking statements as representing the company fees as of any date subsequent to the data this presentation.

On slide three agenda, you'll see the agenda for today and it is as follows.

Lucinda Crabtree: On slide three, Agenda, you'll see the agenda for today, and it is as follows: Christian will provide a brief introduction, and that will be followed by our operational highlights for the second quarter of 2020. Andrew will next discuss the company's financial results, and then Christian will conclude with upcoming milestones and other concluding comments. And, of course, we will welcome your questions following our remarks. So with that, I'd like to turn the call over to Christian.

Christian will provide a brief instruction and that will be followed by our operational highlights for the second quarter of Twentytwenty.

Andrew will discuss the Companys financial results on a Christian will conclude with upcoming milestones and other concluding comments.

And of course, we will welcome your questions following our remarks.

So with that I'd like who tend to close the to Christian.

Christian Martin Itin: All right. Well, thank you very much, Lucinda. This is probably the most thorough, all forward-looking statement that I think we have had. So with that, good morning to everyone, and thank you for joining us. I'm pleased to review our progress for the second quarter of 2020. First, on slide five, I would like to update you on the current and potential future impact of the COVID-19 pandemic on our business. At our last financial update call in May, we were at the height of the first peak of the COVID-19 infection in the New York City metropolitan area, the UK, and Spain. Patients, and for some weeks, patients could not be enrolled into clinical trials in those areas. In contrast, sites in the south of the U.S. continue to operate normally during that period and continue to enroll order three patients.

Alright, well. Thank you very much the same does this is probably the most thorough all forward looking statements today I think we had so with that good morning to everyone and thank you for joining us I'm pleased to review our progress for the second quarter, 2021st on slide five I would like to ups.

Thank you on the current and potential future impact of recovery 19 pandemic on our business.

The last financial update call in May we were at the height of the first peak of the current margin infection in New York City Metropolitan area. The UK.

And Spain.

The patients whilst and for some weeks patients could not be enrolled into clinical trials in those areas. In contrast sites and the size of the U.S. continue to operate normally during that period and continue to enroll order three patients.

Christian Martin Itin: In parallel, the startup of our auto one pi pivotal study in Q2 has been progressing to plan. While we're now in a more stable situation in the first hit areas, and patient enrollment has resumed, we are monitoring with some concern the developments in the south and the west of the US. While we continue to enroll patients in those areas, we're closely monitoring the situation. Our key focus is on patient safety and ensuring data integrity in our trials. Most of our suppliers have been coping well through the first stretch of the pandemic, while some have experienced issues. We are working closely with all our suppliers to ensure an uninterrupted supply of essential goods and services for our operations.

In parallel the startup of our auto one pipe pivotal study in Q2 has been progressing to plan.

While we are now in a more stable situation in the first hit area and patient enrollment resumed we are monitoring with some concern but developments in the south and west of the U.S., while we continue to enroll patients in those areas. We're closely monitoring the situation. Our key focus is on patient safety and ensuring data integrity in our trials.

Most of our suppliers have been coping well through the first stretch of the pandemic, while some have experienced issues. We're working closely with all our suppliers to ensure uninterrupted supply for essential goods and services for our operations. Finally, we've been working closely with our logistics partners to ensure uninterrupted and timely.

Christian Martin Itin: Finally, we've been working closely with our logistics partners to ensure uninterrupted and timely continental and transatlantic deliveries of Leucophoresis and final products. To date, our LEAP programs, Order 1 and Order 3, have not been significantly impacted by the COVID-19 outbreak. However, depending on the development of the pandemic in the second half of 2020 and into 2021, our trials could become impacted. For Auto IV, we experienced a delay in patient involvement for our ongoing Phase I clinical trial. This trial is conducted in the UK and in Spain, and the healthcare systems in both countries have been heavily impacted, leading to a stop in involvement in the second quarter. However, the return to normal activity in both countries has been slower than expected, and we now expect first data from this Phase I study to be available in the first half of 2021 instead of the fourth quarter of 2020. With respect to our preclinical programs, these have been minimally impacted.

Continental and transatlantic deliveries of Luca for research and final products.

To date, our lead programs auto Walnut order three have not been significantly impacted by the covet 19 outbreak. However, depending on the development of the pandemic and the second half was 2020 and into Twentytwenty won our trials could become impacted.

For auto for we experienced a delay in patient enrollment for our ongoing phase one clinical trial. This trial is conducted in the UK and in Spain, and healthcare systems in both countries have been heavily impacted leading to stop of enrollment in the second quarter. The returned to normal activity in both countries has been slower than expected and we now expect first data.

From this phase one study to be available in the first half of 2021, instead of the fourth quarter of Twentytwenty.

With respect to our preclinical programs these have been minimally impacted.

Christian Martin Itin: And we continue to expect AUTO5, AUTO6-NG, and AUTO7 to enter clinical development in 2021. Our first clinical studies with AUTO1-NG in pediatric ALL and AUTO8 in multiple myeloma remain on track to begin in the second half of 2020. So moving on to our corporate highlights, starting with our clinical programs on slide six. We've had a busy quarter across our portfolio, with positive data presentations at key medical conferences. Both our later stage clinical programs, Auto I and Auto III, continue to show very encouraging clinical activity with tolerable safety profiles, as highlighted in two separate presentations at ASCO and EHA. We will also follow both these presentations with analyst events.

We continue to expect auto five or six Angie auto seven to enter the clinic, the clinical development and Twentytwenty one.

Our first clinical studies with auto on LNG, and pediatric JLL and automate in multiple myeloma remain on track to begin in the second half of Twentytwenty.

Moving onto our corporate highlights and starting with our clinical programs on slide six we've had a busy quarter across our portfolio with positive data presentations at key medical conferences.

Both our later stage clinical programs auto and auto three continued to show very encouraging clinical activity with tolerable safety profiles as highlighted in two separate presentations at ASCO and EHA AJ. We also follow both these presentations with analyst events I will touch on these clinical updates a little later however.

Christian Martin Itin: I will touch on these clinical updates a little later. However, focusing on the operational aspects and starting with Auto I, we have now commenced enrollment of patients with relapsing-remitting adult acute lymphoblastic leukemia in our pivotal Phase I-B-II Auto I program, and we're targeting to have data by the end of 2021. With regard to our lead product candidate for the treatment of DL-BCL, Auto III, we have now selected the recommended Phase II range of 150 to 450 million cells with a single dose of pembrolizumab included in preconditioning.

Focusing on the operational aspects and starting with auto one we have now commenced enrollment of patients with relapsing remitting adult acute lymphoblastic leukemia, and our pivotal phase lumpy to auto loan program and we're targeting to have stayed up by the end of Twentytwenty loan with regards to our lead product candidate for the treatment of deal DCIO auto three.

We have now selected the recommended phase two arranged all four on hundred 52 450 million cells, where the single dose of Pembrolizumab included in Preconditioning. In addition, the company has also commenced a 20 patient by patient cohort as an extension to its ongoing phase one two Alexander study with results expected by the end of 2020.

Christian Martin Itin: In addition, the company has also commenced a 20-patient outpatient cohort as an extension to its ongoing Phase I-II Alexander study, with results expected by the end of 2020. The data from this outpatient cohort will provide important insights that will be used to refine the design of the potential pivotal phase two part of the Alexander study. Finally, we're also pleased to have been invited to present a mini oral presentation at ESMON on September 18, 2020, where we'll give a further clinical update from the Alexander study. On that note, we plan to host an analyst event on that same day.

The data from this out patient cohorts will provide important insights that will be used to refine the design of the potential pivotal phase two part of the Alexander study.

Finally, we're also pleased to have been invited to present, a mini oral presentation at ESMO on September 18, 2020, where we'll give a further our clinical update from the Alexander study on that note. We plan to host an analyst event on the same day.

Christian Martin Itin: Finally, the last item I would like to mention on this slide is other forthcoming clinical data updates expected through the second half of 2020. For Auto I and adult ALL, we plan to present longer-term follow-up data towards the end of 2020, likely at ASH. For Auto III, as I've mentioned, we would look to update with additional patients from our ongoing Alexander study, as well as longer-term follow-up data at ESMO. We would also look to provide a further update by the end of 2020, again likely at ASH, by which time we would also look to update you on the data from the outpatient cohort. Moving to slide 7. At AACR, we gave an update on three of our earlier stage pipeline programs, Auto V, Auto VI-NG, and an oral presentation on Auto VII. The preclinical data presented reinforced the strength of our binder discovery capabilities with our ability to selectively target two separate populations of T cells in T cell lymphoma as defined by the mutually exclusive expression of T cell receptor beta chain constant domains one and two.

Finally, the last item I would not I would we'd like to mention on this slide is other forthcoming clinical data updates expected through the second half of 2020 fraud Obama and adult MLL, we plan to present longer term follow up data towards the end of 2020 likely at ash for a three as I've mentioned, we would look to update with additional patients from.

Our ongoing Alexander study as well as longer term follow up data to asphalt. We would also look to provide a further update by the end of 2020 again likely at ash by which time. We would also look to update you on the data from the outpatient covert moving to slide seven.

HCR, we updated on three of our earliest stage pipeline programs auto five or six Mg and an oral presentation on August seven.

The preclinical data presented reinforced the strengths of our binder discovery capabilities with our ability to selectively target two separate populations of T cells and T cell lymphoma as defined by the mutual exclusive expression of T cell receptor better chain constant domains, one and two.

We're excited about the profile of auto five our anti TRP see two comerica antigen receptor.

Which is the complimentary program to our clinical asset or four which targets TRP seat one positive T cells.

Christian Martin Itin: We're excited about the profile of AUTO5, our anti-TRBC2 chimeric antigen receptor, which is the complementary program to our clinical asset, AUTO4, which targets TRBC1 positive. In addition, we also demonstrated the utility of our broad technology toolkit, whereby we showed how our modular approaches in Auto6NG and Auto7 can address the hostile solid tumor microenvironment in models of small cell lung cancer and prostate cancer, respectively. The new data suggest that Auto6NG can overcome key immune suppressive mechanisms in the tumor microenvironment.

In addition, we also demonstrated utility of our broad technology tool kit, whereby we showed how our modular approaches in auto six Angie and older seven can address the hostile solid tumor micro environment in models of small cell lung cancer and prostate cancer respectively.

The new data suggest that ought to six Angie can overcome key immune suppressive mechanisms in the tumor microenvironment. Furthermore, the older seven program builds on the novel and optimized car to peer sinay designed to be highly active even with load Pearson may target expression and also in and then acidic environment offering correctors stick for solid tumors.

Although seven then combined modules introduced in order to 60 Mg with a novel module, leading to a low level secretion of interleukin 12 to change the prostate tumor from immunologically hostile to minimum illogical logically supportive environment.

Christian Martin Itin: Furthermore, the Auto7 program builds on a novel and optimized card to PSMA, designed to be highly active even with low PSMA target expression and also in an acidic environment, often characteristic of solid tumors. AUTO7 then combines modules introduced in AUTO6-NG with a novel module leading to a low-level secretion of interleukin-12 to change the prostate tumor from an immunologically hostile to an immunologically supportive environment. We've guided that all three programs presented at AACR, Auto V, Auto VI-NG, and Auto VII, are expected to enter the clinic in 2021. Moving to slide number eight.

We've guided at all three programs presented at a CR auto five or six Angie and auto seven are expected to enter the clinic and Twentytwenty bomb.

Moving to slide number eight.

Given the maturing of our clinical huh.

I'd to announce earlier this week Dr. Jay backs terms appointment to the board of directors Jay brings a wealth of oncology development regulatory and portfolio strategy experience to the board under his leadership Celgene has developed a broad range of therapeutics, including small molecules biologicals and car T programs in one of the industry's most significant hemato.

Christian Martin Itin: Given the maturing of our clinical program, I did announce earlier this week Dr. Jay Backstrom's appointment to the Board of Directors. Jay brings a wealth of oncology development, regulatory, and portfolio strategy experience to the board. Under his leadership, Celgene has developed a broad range of therapeutics, including small molecules, biologicals, and CAR-T programs into one of the industry's most significant hemato-oncology pipelines. Furthermore, we also announced Dr. Nushnia Kokar's promotion to Senior Vice President, Clinical Development, taking over full responsibility for all our clinical development activities. Nushmi has been instrumental in the development of our clinical programs at Autolus, and we very much look forward to her continued strong leadership. Finally, we now inform you that Dr. Vijay Peddareddigari will be leaving the company, moving with his young family back to the U.S. Over the past four years, Vijay has played a key leadership role in establishing and executing the clinical development strategy to advance our program T-cell Moving to slide number nine.

On quality pipelines.

Furthermore, we also now in stock dilution Echo cars promotion to senior Vice President clinical development, taking over full responsibility for all our clinical development activities Notionally has been instrumental in the development of our clinical programs at our list and we are very much look forward to her continued strong leadership.

Finally, we announced that Dr. VJ pad ready Gary will be leaving the company moving with his young family back to the us over the past four years feature has played a key leadership role in establishing an executing the clinical development strategy to advance our program T cell therapies, and we do wish him well in his future endeavors.

As well as the board and management update worth mentioning that were also extending our manufacturing capacity cell and gene therapy catapult to secure initial commercial launch capability.

Moving to slide number nine.

I wanted to spend a brief moment recapping our lead program auto loan in adult MLL adult MLL is a challenging disease and typically disease of elderly patients a lot of these patients has significant co morbidities, making them a more fragile patient group pending PNM pediatric JLL.

The indication is approximately three times the size of pediatric L. L, which represents an attractive market opportunity within the U.S. and the top five European countries. Approximately 3000 patients every year at the are at the end stage of their treatment, having failed chemotherapy and stem cell transplant and therefore require.

Christian Martin Itin: I wanted to spend a brief moment recapping our lead program, Auto One, in adult ALL. Adult ALL is a challenging disease and typically a disease of elderly patients. A lot of these patients have significant comorbidities, making them a more fragile patient group than in pediatric ALL. The indication is approximately three times the size of pediatric ALL, which represents an attractive market opportunity. Within the US and the top five European countries, approximately 3,000 patients every year are at the end stage of their treatment, having failed chemotherapy and stem cell transplant, and therefore require other options. However, at this point, there is no CAR T therapy approved for adult ALL.

Other options at this point there is no car T therapy approved for adult MLL.

When we created when we created auto Hum. We wanted we designed a product that has an ability to have a very high level of anti leukemic activity to cope with the rapid growth that leukemic cells in the bone marrow, a very long persistence to put long term pressure on the leukemia and get to transformational outcome combined with a two.

Tolerable safety profile, which is particularly important for elderly patients with acute leukemia.

Now turning to slide number 10 to recap on the updated provided a D.A.J. in June on the all car 19 study with auto one Oh data suggest that order one has a superior efficacy profile with a comfortable safety profile to standard of care. The overall response rate and MRT negative CR rate was we presented at DHL was 80.

Christian Martin Itin: When we created Auto One, we designed a product that has the ability to have a very high level of anti-leukemic activity to cope with the rapid growth of leukemic cells in the bone marrow, and a very long persistence to put long-term pressure on the leukemia and get to a transformational outcome, combined with a tolerable safety profile, which is particularly important for elderly patients with acute leukemia. Now, turning to slide number 10, to recap the update we provided at EHA in June on the All-CAR-19 study with OTA-1. Our data suggests that OTA-1 has a superior efficacy profile with a comparable safety profile to standard of care.

4% for all 19 patients treated in this study responses appear durable and notably first patients are beyond 18 months in molecular complete remission without receiving a second transplant in fact for older patients treated only two patients have been consolidated with a transplant overall 11 of the 19 patients continue.

Ptcs free where the median follow up of 12.2 months with the range ongoing up to a 24.4 months.

Now, putting the state and contacts with somebody other standard of care therapies that are available. The overall response rate. We see is approximately double that of during the two AMAP and looking at event free survival or median PFS is also compares very favorably to blend a tumor have or in a tusa map where approximately half the patients are consolidated with transplant.

Christian Martin Itin: The overall response rate and MRD negative CR rate we presented at EHA was 84% for all 19 patients treated in this study. Responses appear durable, and notably, the first patients are beyond 18 months in molecular complete remission without receiving a second transplant. In fact, for all the patients treated, only two patients have been consolidated with a transplant. Overall, 11 of the 19 patients continue to be disease-free with a median follow-up of 12.2 months, with the range going up to 24.4 months. Now, putting this data in context with some of the other standard of care therapies that are available, the overall response rate we see is approximately double that of Blinatumumab. And looking at the Ventri survival or median PFS, this also compares very favorably to Blinatumumab or Inotuzumab, where approximately half the patients are consolidated with transmission. Furthermore, Auto-One event-free survival at six months is high at 62% for all patients and 76% for patients treated with the close manufacturing process, which we're using going forward in the pivotal studies. In the absence of post-CAR T consolidation with transplants, the treatment effect is that of Auto-One as a standalone.

Furthermore, Autobahn event free survival at six months is high at 62% for all patients and 76% for patients treated with the close manufacturing process, which were using going forward in the pivotal study.

With the absence of post car T consultation with transplants. The treatment effect is that of auto one as a standalone therapy.

Based on this data turning to slide 11, that's started enrollment into the pivotal program auto won a alarm in adult MLL as a reminder to CK was filed in the UK in Q1 and cleared earlier.

This year and the U.S. I'd was accepted by the FDA and the second quarter, we have now sites open and running and enrolling patients. As a reminder, the study has a phase lumpy running and the pivotal program comprises a single on 100 patients study with relapsed refractory patients. The primary endpoint is complete remission rate secondary endpoints include.

Molecular Crs event free survival and duration of response, we remain on track to report full data by the end this 21.

Let's now turn to slide 12, where I would like to switch gears and talk about auto three program that is designed for the treatment of patients with diffuse large b cell lymphoma.

Christian Martin Itin: So based on this data, turning to slide 11, we have started enrollment into the Pivotal program, Auto 1 AL1 in adult ALL. As a reminder, the CTA was filed in the UK in Q1 and cleared earlier this year, and the US ID was accepted by the FDA in the second quarter. We now have sites open and running and are enrolling patients. As a reminder, the study is in phase 1b run-in, and the Pivotal program comprises a single-arm 100-patient study with relapsed refractory patients. The primary endpoint is complete remission rate. Secondary endpoints include molecular CRs, event-free survival, and duration of response. We remain on track to report full data by the end of 2021. Now, let's turn to slide 12, where I would like to switch gears and talk about Auto3, a program that is designed for the treatment of patients with diffuse large B-cell lymphoma. As you all know, DLBC is a much bigger indication than adult DLL in a setting where there are already two approved CAR-T therapies, which are CAR-T and Kymriah, plus Lizazel, or otherwise known as JCAR-17, pending approval.

As you all know DLP. She has a much bigger indication that at all day Ll anesthetic, where there are already to approve car T therapy, with just carton, Kim rider plus lives or sale or otherwise known as Jake her 17 pending approval. We know this is a large opportunity with approximately 10000 patients on the back end of the disease, which is a sizable population where the very.

Significant medical need.

The aim in D.C.L. is to achieve durable complete remissions approved car T products just start in Cumbria have a high objective response rate between 70, 80%, but only 29% to 37% of the patient achieve durable complete remissions. The two main drivers for relapses post remission, our loss of antigen and expression of PD L.

Obama on lymphoma cells.

The other three is designed to achieve a high level of sustained complete remissions to contract loss advantage and as innovation mechanism. The engineer to Comerica antigen receptor is one targeting cdnineteen cdtwenty two into each car T cell. The rationale is set the lymphoma sale would have to lose both antigen simultaneously to avoid recognition by the car T.

Christian Martin Itin: We know this is a large opportunity with approximately 10,000 patients on the back end of the disease, which is a sizable population with a very significant medical need. The aim of DLD-CL is to achieve durable, complete remissions. Approved CAR-T products, Jaskarta and Kymriah, have a high objective response rate between 70 and 80 percent, but only 29 to 37 percent of patients achieve durable, complete remissions. The two main drivers for relapses post-remission are loss of antigen and expression of PD-L1 on lymphoma. Auto3 is designed to achieve a high level of sustained, complete remissions. To counteract loss of antigen as an evasion mechanism, we engineered two chimeric antigen receptors, one targeting CD19, and the other CD22, into each CAR T cell. The rationale is that the lymphoma cell would have to lose both antigens simultaneously to avoid recognition by the CAR T cell, a much less likely event to occur than a single antigen loss.

Well, a much less likely than to occur than a single antigen loss.

Molecular composition of our cars, it's different from any other car T product even from auto one with different binders targeting the antigens a different costimulatory domain for the Cdnineteen car and an hour car architecture for the CD 22 car.

In addition to the unique molecular design of our three we're also using Pembrolizumab joined Preconditioning to counteract PDL one mediated checkpoint inhibition.

As reported Askren DHL older three shows a high level of complete remissions with about 60% see ours at the recommended phase two dose.

Moving to slide 13, encouragingly today to have been no early reads out phase observed from patients, who achieve tiers, which bodes well for sustained high level of see ours.

Larger patient numbers more follow up will provide further clarity towards the end of this year.

Christian Martin Itin: The molecular composition of our CARs is different from any other CAR-T product, even from Auto-1, with different binders targeting the antigens, a different co-stimulatory domain for the CD19-CAR, and a novel CAR architecture for the CD22-CAR. In addition to the unique molecular design of ORAL-3, we're also using Pembrolizumab during preconditioning to counter As reported at ASCO and EHA, OTA3 shows a high level of complete remissions with about 60% CRs at the recommended phase 2 dose. Moving to slide 13.

Slide 14, importantly patients responding to obviously therapy showed eliminate car T related toxicities supporting treatment of patients outside of academic centers and also in outpatient setting. This is particularly important in deal Bcl as 80% of third line patients are treated outside academic centers in the U.S.

Currently approved products are only tapping into say significantly less than 20% of the market, which is managed by the academic centers is very little to no penetration of the remaining 80% of the market, which comprise settings that cannot deal with the intensity of management required for the current T. A car T products.

Christian Martin Itin: Encouragingly, to date, there have been no early resapses observed from patients who achieved CRs, which bodes well for sustained high levels of CRs. Larger patient numbers and more follow-up will provide further clarity towards the end of this year. Slide 14.

I believe this creates a highly attractive opportunity for the profile of product that we're seeing with over three as I've mentioned, we expect to provide an update on patients treated in outpatient expansion cohort by the end just 2020.

Christian Martin Itin: Importantly, patients responding to autoimmune therapy showed limited CAR T-related toxicities, supporting treatment of patients outside of academic centers and also in outpatient settings. This is particularly important in DLBCL, as 80% of third-line patients are treated outside academic centers in the U.S. Currently, approved products are only tapping into significantly less than 20% of the market, which is managed by academic centers.

So, let's turn to slide 15.

As we have discussed with develop the first in class Cdnineteen and Cdtwenty two car with novel signaling domains to designed to provide best in class efficacy with high rates of durable complete responses given the differentiated clinical and safety profile. We have reported on so far we see a really attractive opportunity for order three as an open.

Patient solution for patients with the obese email therefore, maximizing the commercial potential of a karkhi product across all settings of care.

Finally on slide 16, I wanted to remind you of the broad an exciting next generation pipeline, we're proud to be developing a nautilus.

Christian Martin Itin: There's very little to no penetration of the remaining 80% of the market, which comprises settings that cannot deal with the intensity of management required for the current T product. We believe this creates a highly attractive opportunity for the profile of product that we're seeing with Auto3. As I've mentioned, we expect to provide an update on patients treated in our outpatient extension cohort by the end of 2020. So, let's turn to slide 15.

Auto one Mg our next generation program in L.L. retains the fast off rate Cdnineteen car, we use in auto loan and as a CD 22 car and novel one we will look to progress. This program into phase one clinical study in the pediatric setting in the second half of this year Cdnineteen negative relapse appears.

To be a greater issue in pediatric patients compared to the all patients per day level and hence the focus with this program first in pediatric patients.

Christian Martin Itin: As we have discussed, we have developed the first in-class CD19 and CD22 CAR with novel signaling domains designed to provide best-in-class efficacy with high rates of durable complete response. Given the differentiated clinical and safety profile we have reported on so far, we see a really attractive opportunity for Auto3 as an outpatient solution for patients with DLV-CL, therefore maximizing the commercial potential of a CAR-T product across all settings Finally, on slide 16, I wanted to remind you of the broad and exciting next generation pipeline we're proud to be developing at Autolus. Auto1NG, our next generation program in ALL, retains the fast off-rate CD19 car we use in Auto1 and adds a CD22 car, a novel one. We will look to progress this program into a Phase 1 clinical study in the pediatric setting in the second half of this year. CD19 negative relapse appears to be a greater issue in pediatric patients compared to adult patients with ALL, and hence the focus with this program first in pediatric patients. Auto3NG is a lifecycle management program at DLBCL and is representative of the ongoing innovation at Autolus.

Although CNG is a lifecycle management program and deal PCL and here. So presented is off the ongoing innovation at Odalis.

I also wanted to mention auto eight which is our next generation program multiple myeloma due to enter the clinic in second half of 2020 as well.

Lastly, the suite of next generation programs, we showcased at a CR a few weeks ago, we will look to move into the clinic in Twentytwenty run, including our first at solid tumor programs for both prostate cancer.

And small cell lung cancer, which rigs today, where it's very exciting to be progressing.

With that I will turn over to Andrew for her second call 2020 financial update Andrew.

Hi, Thanks, Christian and good morning, all good afternoon to everyone.

If we move to slide in the next slide.

It's my pleasure to review our financial results for the second quarter.

That's for June June 30, Twentytwenty, I'm, starting with our cash position in cash and cash equivalents at other cities June totaled $212 million on that compared with $243 million at the end of the previous quarter.

Total operating expenses for the three months ended Thirtyth June 2020, with $39.5 million, that's measured granting pellets zero point $3 million and that compared to net operating expenses of $37.2 million net.

Christian Martin Itin: I also wanted to mention AutoAid, which is our next-generation program for multiple myeloma due to enter the clinic in the second half of 2020 as well. Lastly, the suite of next-generation programs we showcased at AACR a few weeks ago. We will look to move into the clinic in 2021, including our first solitumer programs for both prostate cancer and small cell lung cancer, which we're excited to be progressing. With that, I will turn it over to Andrew for our second cold 2020 financial update. Andrew.

Granting come at the same amount for the same period in 2019.

Research and development expenses increased to 31.3 million for the three months intensity as of June from 26.2 million for the three months ended Thirtys at June 2019.

Cash costs, which exclude depreciation and amortization as follows share based compensation increased to $26.5 million from $20.2 million. The increase in research and development cash cost of $6.3 million consisted primarily of one an increase in compensation and employment related costs, that's net though lower.

Andrew Oakley: Thanks, Christian. And good morning or good afternoon to everyone. If we move to the next slide, the next slide, it's my pleasure to review our financial results for the second quarter. That's for June 30, 2020. Starting with our cash position, cash and cash equivalents at the 30th of June totaled $212 million.

No cost as a result, with the ongoing pandemic $1.8 million, that's due to an increase in employee headcount to support the advancement of that product candidates in clinical development Secondly, an increase of $3 million in project expenses as a consequence of the advancement of our clinical portfolio, which includes all of the research process development none effect.

Andrew Oakley: And that compared with $243 million at the end of the previous quarter. Net total operating expenses for the three months ended 30th June 2020 were $39.5 million, that's net of grant income of $0.3 million, and that compared to net operating expenses of $37.2 million, net of grant income of the same amount for the same period in 2019. Research and development expenses increased to $31.3 million for the three months ended 30th June from $26.2 million for the three months ended 30th June 2019. Cash costs, which exclude depreciation and amortization, as well as share-based compensation, increased to $26.5 million from $20.2 million.

During antibodies necessary cheaper pay activate and monitor the clinical trial programs.

Thirdly, an increase of $1.3 million in facility costs related to the commencement of the lease for an additional manufacturing suite and the continued scaling of operations in the manufacturing facility.

And lastly, eight an increase in 90 and telecoms General office expense and professional fees of six zero point $6 million, which is offset by a decrease in materials purchases.

$400000.

Non cash costs decreased $4.8 million for the three months, so anything city as of June from 6 million to the three three months ended Thirtyth of Gen. 2019. This decrease is primarily related to share based compensation expense. What's included in research and development expenses, which takes.

Andrew Oakley: The increase in research and development cash costs of $6.3 million consisted primarily of one, an increase in compensation and employment-related costs that was net, though, of lower travel costs as a result of the ongoing pandemic of $1.8 million, and that was due to an increase in employee headcount to support the advancement of our product candidates in clinical development. Secondly, an increase of $3 million in project expenses as a consequence of the advancement of our clinical portfolio, which includes all of the research, process development, and manufacturing activities necessary to prepare, activate, and monitor the clinical trial program. Thirdly, an increase of $1.3 million in facility costs related to the commencement of the lease for an additional manufacturing suite and the continued scaling of operations in the manufacturing facility. And lastly, an increase in IT and telecom general office expense and professional fees of $0.6 million, which is offset by a decrease in materials purchases of $400,000.

We spent $1.3 million as result of below a fair value of stock options recognized in the period and this was offset offset by a small increase in depreciation.

General and administrative expenses decreased $8.5 million for the three months ended 30, Isagen Twentytwenty from 11.4 million for three months ending city as of June 2019.

Cash costs, which as I've explained exclude depreciation as well as chip based expense compensation.

Decreased to $6.7 million from $7.3 million for the previous the corresponding quarter last year.

Compensation related expenses decreased by 100000 aided by lower travel costs as described above.

There was a decrease of zero point $7 million in commercial activities and these decreases were offset by a marginal increase in legal and professional fees of $100000.

Andrew Oakley: Non-cash costs decreased to $4.8 million for the three months ending 30th June, from $6 million for the three months ending 30th June 2019. This decrease is primarily related to share-based compensation expense that's included in research and development expenses, which decreased by $1.3 million as a result of the lower fair value of stock options recognized in the period, and this was offset by a small increase in depreciation. General and administrative expenses decreased to $8.5 million for the three months ended 30th of June 2020 from $11.4 million for the three months ending 30th of June 2019, cash costs, which, as I've explained, exclude depreciation, as well as share-based expense compensation, decreased to $6.7 million from $7.3 million for the previous corresponding quarter last year.

Non cash costs decreased to $1.8 million for three months ended Thirtyth of June 2020 from $3.9 million for three months ended cities at June 2019. The decrease is attributable to share based compensation expense as a result at the lower fair value of stock options being recognized cheers.

In the period.

Interest income decreased by $1.1 million for the three months due to lower interest rates. Other income decreased 2.0 point 5 million for the three months ended Thirtyth of June Twentytwenty from other income of 4.4 million for three months, primarily related to decrease the exchange rate between the UK.

And the pound.

For the three months ending third as of June 2020, as compared to the three months ending cities of June 2019.

Income tax benefit increased to $7 million for these three months ending Thirtyth of June 2020 from $3.3 million. This corresponding period last year and that's due to increased R&D expenses, which led to an effective higher effective tax rate.

Andrew Oakley: Compensation-related expenses decreased by $100,000, aided by lower travel costs as described above. Further, there was a decrease of $0.7 million in commercial activities, and these decreases were offset by a marginal increase in legal and professional fees of $100,000. Non-cash costs decreased to $1.8 million for the three months ended 30th June 2020 from $3.9 million for the three months ended 30th June 2019. The decrease is attributed to share-based compensation expense as a result of the lower fair value of stock options being recognized during the period. Interest income decreased by $1.1 million for the three months due to lower interest rates.

Research and development credits are obtained at a maximum rate of 33.35% for qualifying research and development expenses and the increase in the net credit was primarily attributable to an increase in that eligible expense.

So overall net loss attributable to ordinary shareholders was $32 million for the three months ending 30 as of June 2020, and that compared to $28.5 million for the corresponding period last year.

This resulted in a basic and diluted net loss per ordinary share for the three months ending city as of June of 62 cents compared to a basic and diluted.

Andrew Oakley: Other income decreased to $0.5 million for the three months ended 30th of June 2020 from $4.4 million for three months primarily related to a decrease in the exchange rate between the UK and the pound for the three months ending 30th of June 2020 as compared to the three months ending 30th of June 2019. The income tax benefit increased to $7 million for the three months ending 30th June 2020 from $3.3 million for the corresponding period last year. And that's due to increased R&D expenses which led to a higher effective tax rate. Research and development credits are obtained at a maximum rate of 33.35% for our qualifying research and development expenses, and the increase in the net credit is primarily attributed to an increase in that eligible expense.

Net loss per ordinary share for the corresponding period last year of 65 cents.

And consistent with the previous guidance the company anticipates that cash on hand provides us with a runway into 2022.

And with that I'll now hand, the call back to Christian to give you a brief outlook on expected milestones Christian.

Thanks, Andrew Let me conclude this part of the management discussion with a review of the upcoming milestones that news flow through 2020, let's move to slide 20.

The upcoming six months, we'll yet be another eventful period for us with multiple clinical milestones and opportunities for value creation, our chief of most eminent operational focus will be continuing enrollment and dosing of patients into pivotal phase on the two trial for auto loan in adult MLL and completing the outpatient court for order three in deal Bcl. We also expect.

Andrew Oakley: So overall, the net loss attributable to ordinary shareholders was $32 million for the three months ending 30th June 2020, and that compared to $28.5 million for the corresponding period last year. And this resulted in a basic and diluted net loss per ordinary share for the three months ending 30th June of 62 cents compared to a basic and diluted net loss per ordinary share for the corresponding period last year of 65 cents.

To report clinical data on the auto three Alexander trial at the forthcoming ESMO meeting and a further update plan for ash and updated on a one all current 19 data also plan for ash.

The second half a 2020, we'll look to progress auto one and GE. Our next generation program for AOL into phase one clinical study in pediatric setting and in the same period. We also expect our next generation multiple myeloma program auto eight to enter the clinic towards the end of the year, we expect to progress our first allogeneic program into clinical development as well as we move.

Andrew Oakley: And consistent with the previous guidance, the company anticipates that cash on hand provides us with a runway into 2022. And with that, I'll now hand the call back to Christian to give you a brief outlook on expected milestones.

Move through to the ended the year and into next year, we will look to progress a number of other our other preclinical candidates to appoint the phase one readiness, including all the five Autistics Mg and other seven which are the programs. We updated you on a CR.

Christian Martin Itin: Thanks, Andrew. Let me conclude this part of the management discussion with a review of the upcoming milestones for news flow through 2020. Let's move to slide 20.

We plan for these programs to enter into the clinic in 2021 finally in the first half of 21, we look forward to providing an interim update on or before in T cell lymphoma, and we expect to present on a smaller number small number of additional patients.

Christian Martin Itin: The upcoming six months will be another eventful period for us with multiple clinical milestones and opportunities for value creation. Our chief and most imminent operational focus will be continuing enrollment and dosing of patients in the Pivotal Phase I-II trial for Auto I in adult ALL and completing the outpatient cohort for Auto III in DLB-CL. We also expect to report clinical data on the Auto III Alexander trial at the forthcoming ESMO meeting and a further update planned for ASH and updated Auto I and G, our next generation program for ALL, into a phase one clinical study in the pediatric setting. And in the same period, we also expect our next generation multiple myeloma program, Auto A, to enter the clinic.

In conclusion on slide 21, I'd like to recap the major messages from today's call. Although on our first pivotal program has started in Q2 as planned given the positive safety and efficacy profile today with belief that auto loan has the potential to be a best in class Cdnineteen car T program in adult MLL their disease, setting with very high unmet need.

Second order three a deal DCIO, we'll have additional clinical data updates at ESMO and possibly ash in Q2, we have initiated the outpatient court with plant data update on that cohort by year end the companies and get into good position and combined with cash on hand of 212 million, we feel well poised for success, we're not happy to take questions.

Christian Martin Itin: Towards the end of the year, we expect to progress our first allogeneic program into clinical development as well. As we move through to the end of the year and into next year, we will look to progress a number of our other preclinical candidates to a point of phase one readiness, including Auto V, Auto VI-MG, and Auto VII, which are the programs we updated you on at ACR. We plan for these programs to enter into the clinic in 2021. Finally, in the first half of 2021, we look forward to providing an interim update on auto-4 and T-cell lymphoma, and we expect to present data on a small number of additional patients. In conclusion, on slide 21, I'd like to recap the major messages from today's call. Auto1, our first pivotal program, has started in Q2 as planned.

Operator.

Please re queue.

The phone lines are now open for questions to ask a question lives. Please press star one on your telephone keypad. Once your name has been announced to me. Then go ahead with your question.

Our first question is from Marigold seen Mizuho Securities USA.

Hello, This American Hanmi.

Yes, Hi, Matt how are you.

Hi, Thanks, Hi, Thanks for taking my questions, just and I just a couple of questions first of all can you Tonight My comment regarding the data update executive has now such as you know additional patient and durability and the like and then I had a question on auto eight and really more around the environment for enrolling patients and nothing.

Myeloma trials getting them, then I'm backstop therapy trials currently underway in the context and the competing late line therapeutic for that to be particularly under the umbrella Wally I now like Covidien talk a little bit about that.

Christian Martin Itin: Given the positive safety and efficacy profile today, we believe that Auto1 has the potential to be a best-in-class CD19 CAR-T program in adult ALL, a disease setting with very high unmet need. Second, Auto3 and DLDCL will have additional clinical data updates at ESMO and possibly ASH. In Q2, we initiated the outpatient cohort with planned data updates on that cohort by year end. The company is in a good position, and combined with cash on hand of $212 million, we feel well poised for success.

Sure.

With regards to the.

The second question I think the environment. We're seeing is certainly one there is a where there's a number of new therapeutic are considered becoming available.

I think the primary focus we see with regards to the.

First approvals is clearly on the U.S. and we'll expect some delay for European approvals.

Our initial work will be a will be executed in Europe, and so we think that from that perspective, we will not yet feel that impacts for by the from the new programs.

Operator: We're now happy to take questions. Thank you. The phone lines are now open for questions. To ask a question live, please press star 1 on your telephone keypad.

From the new programs coming in.

Mara Goldstein: Once your name has been announced, you may then go ahead. Our first question is from Mara Goldstein, Mizzou Security. Hello, this is Mara. Can you hear me?

And then I'm asking do you have to repeat the first question military.

Right and were there any data update today knowledge base and additional some color on what we can expect interns that additional patients durability and alike.

Christian Martin Itin: Yes, hi Mala, how are you? Hi, thanks. Sorry, thanks for taking the questions. Just a couple of questions. First of all, can you provide some more color regarding the data updates expected at ESMO, such as, you know, additional patients and durability and the like? And then I had a question on AI and really more around the environment for enrolling patients in multiple myeloma trials, given the number of cell therapy trials currently underway and the competing late-line therapeutics for that disease, particularly under the umbrella of where we are now with COVID. Talk Sure.

Thanks Mark.

Yes, the answer in terms of additional data updates that we had updated at.

ASCO was based on a data cost obviously in early <unk> early part of the second quarter.

Got it included at that 0.8 patients that were at the recommended phase two dose we've completed the that cohort.

Which is a total of about 50 patients will have additional follow up obviously on these patients not only response data, but also follow update on these from these patients. So these are the round out the recommended phase two dose Ics ins for the program that will be sort of the key focus for the has not present at an event as we go towards ash, we expect to be able to ask.

Christian Martin Itin: With regard to the second question, I think the environment we're seeing is certainly one where there are a number of new therapeutic options that are becoming available. I think the primary focus we see with regard to the first approvals is clearly the U.S., and we'll expect some delay for European approvals. Our initial work will be carried out in Europe, and so we think that from that perspective, we will not yet feel an impact from the new programs coming in. And then I'm asking, do you have to repeat the first question? Right, just regarding data updates at ESMA, would you be able to give us some additional information, some color on what we can expect in terms of additional patients, durability, and the like? Thanks, Mara.

The patients experience from the high patient cohort now for the hearing.

[laughter], if I guess that final question and it's on auto three outpatient program and within that protocol defined get outpatient like I guess, what what can be considered success from an outpatient per second at what point. It when patients are treated if they have.

In emerging event and hand that having to go to hospital do they then I didn't keep hitting outpatient failure in CLL.

Christian Martin Itin: Yes, so in terms of additional data updates, what we had updated at ASCO was based on a data cut obviously in the early part of the second quarter, and it included at that point eight patients that were at the recommended phase two dose. We've completed that cohort, which is a total of about 15 patients. We'll have additional follow-up mostly on these patients, not only response data but also follow-up data from these patients. So we'll sort of round out the recommended phase two dose experience for the program. That will be sort of the key focus for the asthma presentation, and then as we go towards ASH, we expect to be able to add the patient experience from the outpatient cohort at the end.

No I mean that the keep the key purpose of the outpatient core it is actually to familiarize dissenters with the product and gain experience with the patients in an outpatient setting understand handling as well as to the overall management.

We have to also understand that obviously the patients, particularly at the very late stage with the disease.

Often require actually hospitalization to manage the disease itself. So this is a lot about gaining experience I'm understanding the profile a understanding the management I'm not a sort of what the key purposes of the of the outpatient cohort and is really laying the foundation to then include a patients in outpatient setting.

Christian Martin Itin: And if I could just ask one more question, and this is on the Auto-Free Outpatient Program, and within the protocol defined as outpatient, what, I guess, would be considered success from an outpatient perspective? At what point when patients are treated, if they have an emergent event and end up having to go to the hospital, do they then become an outpatient failure, if you will?

In a pivotal study as well.

Alright, Thank you very much.

The next month.

Our next question comes from Aaron I mean from Jefferies.

Yeah, Hi, guys I'm, thanks for taking my questions.

Christian just on the outpatient cohort, our patience dose with powerful access regimen of I'll say inhibitors Andhra steroids.

Iberia and out the answer is no or they're not going to be.

Christian Martin Itin: No, I mean, the key purpose of the outpatient cohort is actually to familiarize centers with the product and gain experience with the patients in an outpatient setting, understand handling, as well as overall management. We have to also understand that, obviously, patients, particularly at the very late stage of the disease, often require actual hospitalization to manage the disease itself. So this is a lot about gaining experience, understanding the profile, understanding the management. And that is sort of what the key purpose is of the outpatient cohort and is really laying the foundation to then include patients in an outpatient setting in a pivotal study. All right, thank you very much. Thanks, Mara. Our next question comes from Biren Amin. Yeah, hi guys.

Managed by you know given in our six monoclonal or steroids for that matter.

And so this the patient will not be managed that way that would not be I think a good way to go.

And just to clarify on this outpatient cohort or the data into the year will that inform you on its utility for use in the pivotal trial next year, India Bcl.

We believe it will and as I pointed out a lot of this is really about gaining experience.

And the and I think in that sense, it's going to be important for the centers to actually gain experience in that setting and the and that is important to lay the foundation to include these patients as well.

And then maybe just one last question or the auto a program what learnings things you take from the auto too.

And apply that to the development of auto eight.

Biren Amin: Thanks for taking my questions. Christian, just on the outpatient cohort, are patients those with a prophylaxis regimen of IL-6 inhibitors and or steroids? Hi, the answer is no.

The one of the key focus that we were putting on or putting into the design of the order. A program is really to drive forward the ability to make very deep cuts and the active at very low levels of off target antigen. Both of those elements. We believe are important to actually trends.

Christian Martin Itin: They're not going to be managed by, you know, giving them IL-6 monoclonal or steroids for that matter. So this patient will not be managed that way. That would not be, I think, a good method.

Induce a profile to create a profile that can lead to higher level of molecular emissions, which is really what we need to aim for which are very stringent molecular emissions in that setting. So that is what that program is designed to do and the results traditional elements to be built into the company had disclosed.

Christian Martin Itin: And just to clarify on this outpatient cohort, will the data at the end of the year inform you on its utility for use in the pivotal trial next year in DL-BCL? We believe it will. And as I pointed out, a lot of this is really about gaining experience. And I think in that sense, it's going to be important for the centers to actually gain experience in that setting. And that it is important to lay the foundation to include these patients as well. And then, maybe just one last question. On the Auto A program, what learnings did you take from Auto II?

Great. Thanks for taking my questions [noise].

Backlog burn.

Our next question comes from Eric Joseph with JP Morgan.

Question.

A follow up on me.

And just went about how to think about the data towards year end when you're describing experience can you just.

Sort of help us with expectations.

So duration of follow up there.

Two.

We expect to be reporting.

Efficacy at that point are primarily safety.

And maybe just an update on on enrollment the dates in that cohort.

Christian Martin Itin: and apply that to the development of auto aids. One of the key focus that we were putting on or putting into the design of the AutoAID program is really to drive for the ability to make very deep cuts and be active at very low levels of target antigen. Both of those elements, we believe, are important to actually induce a profile or create a profile that can lead to a high level of molecular remissions, which is really what we need to aim for, which are very stringent molecular remissions in that. So that is what the program is designed to do, and there are also additional elements that we built in that we haven't yet. Great

Hi, Eric Thanks for joining.

I'm not sure whether the entire question books was fully audible on the recording.

I think the key question is what is the type of data we expect by year end for order three and in terms of follow up a safety etcetera, So I think with.

Guards to the cohort the that defines the recommended phase two dose.

Obviously that core it has been fully enrolled and the and patients have been treated before middle of the year and so we'll have a very good a follow up in that patient group of three months and more which gives us a very good view in terms of not only the.

Biren Amin: Thanks for taking my questions. Thanks a lot, Barron. Thank you. Our next question comes from Eric Joseph with J.P., follow up there, expect to be reporting. I think you can see at that point they're primarily safe, and maybe just an update on enrollment. Hi Eric, thanks for joining us. I'm not sure whether the entire question was fully audible on the recording.

Right at one months, but also starting to get to feel for to sustain CR rate. We've already obviously had patients that are we have now.

Eric William Joseph: I think the key question is what type of data we expect by year-end for Auto 3 in terms of follow-up safety, etc. So I think with regard to the cohort that defined the recommended phase 2 dose, obviously, that cohort has been fully involved, and patients have been treated before the middle of the year. And so we'll have very good follow-up in that patient group for three months and more, which gives us a very good view in terms of not only the CR rate at one month but also starting to get a feel for the sustained CR rate. We've already obviously had patients that we have now, observed for 18 months or longer, and obviously that gives us a very good view in terms of the totality of the CRs that we have induced, gives us a very good view over an extended period of time of how these patients are faring, and I think with that, we'll get a very good understanding of what the durable complete remission rate will look like with Auto III.

Observe for 18 months.

Or longer.

And obviously that gives us a very good view in terms of that totality of the Crs that we and do we have fair.

We have a induced give us a very good view over an extended period of time or how these patients are faring I think with that we'll get a very good understanding of what the durable complete remission rate will look like.

With all the three so I think that is a very important part of the data.

The second part overseas is you know a in a larger patient group, obviously, a cooperation of the overall safety profile of the product, which is important feature of off of our three that's I think we're gonna have offices. Substantive addition in terms of with the additional 20 patients that were enrolling.

Eric William Joseph: So I think that is a very important part of the data. The second part is obviously, you know, in a larger patient group, obviously a corroboration of the overall safety profile of the product, which is an important feature of Auto III, and so I think we're going to have obviously a substantive addition in terms of the additional 20 patients that we're enrolling to give us a very robust data set, both on the safety overall, but also from an overall CR rate perspective, and with regard to durability of Okay, great. I guess, short of seeing similar safety in the outpatient cohort, is there really anything in terms of logistics, the ability to manage patients in the outpatient setting that would lead you to not pursue it in a pivotal study?

To give us a very robust dataset both.

On the safety over a little bit also.

From an overall CR rate perspective, and with regards to durability of effect, obviously older patients with treated until now we'll have at least three months a follow up and that gives us a very good view.

Of the the ability.

Of those see owners to sustain overtime.

Okay, Great I.

I guess short of seeing similar safety.

In the patient cohort is there really anything in terms of.

Logistics, the ability to manage patients EMEA patient betting that were.

Or manage patients in the patient cohort that would.

Lead you to not pursuing in a pivotal.

Sorry.

I think it is really about corroborating the data we have in this setting.

Christian Martin Itin: I think it is really about corroborating the data we have in this setting and, as I indicated, an ability for the centers to gain experience. You know, the current experience with CAR-T is to use CAR-Ts predominantly in an inpatient setting. That is what all the guidelines are directed at.

And as I indicated.

The ability for the centers to gain experience.

You know that the current experienced with car T is to use to car T is predominantly an inpatient setting that is what all the guidelines are directly to this is pretty much what the safety management et cetera is really focused on.

Christian Martin Itin: This is pretty much what safety management, et cetera, is really focused on. And so it does take experience, and I think this is what the patient cohort actually allows us to start to build, and I think it will be important as we look forward in this program. But it is, you know, on the pure safety data side, I think corroboration of the data is important. You know, getting a better understanding of, you know, duration of adverse events and those types of information as well, I think will be very helpful in understanding the overall profile and, you know, preparing ourselves to include those patients going forward. Okay, I got it.

And so it does take experience and I think this is what are the that patient cohort actually allows us to start to build.

I think will be important das we're looking forward in this program, but it is on the on the pure safety data side I think corroborating. The data is important I'm getting a better understanding of you know duration of adverse events and those types of information as well I think we'll be very helpful.

In understanding the overall profile and the preparing.

Our sales to include those patients going forward as well.

Eric William Joseph: Thanks for taking the question. Thanks a lot, Eric. Bye-bye.

Okay got it thanks for taking my question.

Thanks, a lot Eric satellite.

Thank you. Our next question is from Convertino from Wells Fargo.

Operator: Thank you. Our next question is from Jim Bertineau of, Hi guys. Congratulations on all the progress. A few questions for me.

Hi, guys congrats on all the progress.

Question for me I guess first just on the outpacing cohort could you remind me remind us again, what the Quakers our per person busy readmitted, where they were going to outpatient setting.

Jim Bertineau: I guess first, just on the outpatient cohort, could you remind us again what the triggers are for patients to be readmitted, you know, if they were dosed in the outpatient setting? And, you know, around fever, you know, the time course of fever that would require readmission. And are you seeing anything early in the outpatient cohort that's giving you confidence that you've got a viable profile for that setting? First of all, thanks for joining us, Jim.

And you know around Hoover whenever the prime course of fever that would require Riyadh listen and arguably one of them early in the output in cohort that said, we're confident that you've got a bible profile for that betting.

So first off thanks for joining Jim a very good questions. Obviously, a the current guidelines in the car T filled and in general for late stage deal DCIO patients is that when patients develop the fever, you want to be sure that do you think that he can exclude.

Christian Martin Itin: Very good questions. Obviously, the current guidelines in the CAR-T field and, in general, for late-stage DLDCL patients, are that when patients develop a fever, you want to be sure that you can exclude an infectious disease. And so typically, these patients do get admitted, get put on an antibiotic, and then are monitored. If obviously the patients are doing well, the fever subsides quickly, the patient can be discharged quickly as well. So the timings around those will be important. And a lot of these patients, whenever they develop fever, whether they're on the therapy or not, will have to go to the hospital, get checked for potential infections, and obviously the risk of sepsis that could develop. And it is really around managing that risk that I think you have to be very mindful and very focused on from a fever perspective. Now, this is no different whether the patient is on CAR-T or the patient is just being managed at that stage of the disease. And there is no difference in terms of the rules that apply and how you actually manage those patients at that point in time in the disease.

Infectious disease.

And so typically these patients do get it made it and get put on it on a on a antibiotic and then armani toward.

If obviously the patients are doing well the fever subsides quickly or the patient can be discharge quickly as well so the timing of the around those will be important and a lot of these patients do whenever they developed people that they're on the therapy or not we'll have to go through the hospital get check.

For potentially infections, and but obviously the risk of sepsis, there could develop and it is really around managing that risk that I think you said you have to be very mindful and very focused on.

From a from a a from a fever perspective now this is no different whether the patient is on Cartier or the patient is just being managed at that stage with the disease.

And there is no different in terms of the rules there apply in how you actually management's patients at that point in time offers disease. So in that regard that is a key parameter. We're looking at in terms of Kennedy early experience I think it's you know it yet, but we don't have enough patients I think to have it I feel a hi, this is going to develop through that.

Christian Martin Itin: So in that regard, that is a key parameter we're looking at in terms of the kind of early experience. I think we don't have enough patients, I think, to have a feel for how this is going to develop through the trial. And, you know, we have to run the cohort and get a good feel for that as we're looking at the 20 patients in total. And then, Krista, maybe a broader question on ability to navigate the pandemic. You referenced the southern U.S. states and the West Coast.

While.

The you know we have to around the cohort and to get a good feel for that the as we're looking at the 20 patients in totality.

And then.

Let me broader question on ability to navigate the pandemic you referenced for southern U.S.K. and the West coast, What's your exposure to sites in those areas and is there a way to adapt to study.

Christian Martin Itin: What's your exposure to sites in those areas? And is there a way to adapt the study to enroll in sites that are less hotspots? Yeah, we do have a significant number of studies across the US, study centers across the US. And this really allows us, and this is now speaking specifically about all three, allows us to actually, you know, focus our enrollment more on the sites that are less impacted. And that actually has worked well so far.

Enrolling sites that are a lot hotspot.

Yeah, we do have a significant number of studies across to you and study centers across the U.S. and Italy and this really allows us for this is now speaking specifically first for all the three.

Allows us to actually.

Focus our enrollment more towards the sites that are less impacted and that actually has worked well so far but it's something you have to be very vigilant about the and the you know you have to monitor very carefully.

Christian Martin Itin: But you know, it's something you have to be very vigilant about. And, and, you know, you have to monitor very carefully. We've seen, certainly in the last month of July, pretty significant and rapid surges in places like Miami or Houston that I think we all hoped we wouldn't see, frankly.

We've seen certainly in the last year during the month of July we've seen in a pretty significant in rapid searches in places like Miami or Houston.

I think we all hope you wouldn't see frankly now those centers still continue to operate the cancer Center still continue to operate.

Christian Martin Itin: Now, those centers still continue to operate; the cancer centers still continue to operate. But it's very clear when you, you know, listen to the public health officials, that some of those places are approaching, or have been approaching, maximal capacity on their ICU beds, etc., which obviously starts then to, you know, put, or present the risk where that could spill over into cancer centers as well. So that's certainly one of the things we're looking very carefully at. From a geographic distribution perspective, we're very well distributed across the US with our centers.

It's very clear that when you listen to the public health officials that some of those places are approaching or have been approaching.

Actual capacity on there how should you be et cetera, which obviously starts tend to.

Put.

Or a present, the risk where that could spill over into into cancer centers as well. So that's that's certainly one of things were looking very carefully hot from a geographic distribution perspective for very well distributed across the U.S. with our centers and obviously, we're also having said this in the UK on the other three side.

Christian Martin Itin: And obviously, we're also having, you know, centers in the UK on the auto three side. And, and there is an element of ability to balance out. And, you know, as you can imagine, while we worked pretty heavily in New York City in the middle of and towards the end of April, we've now actually enrolled quite a few patients outside of New York. So, so it's really kind of managing as the pandemic kind of flows through the country, managing accordingly, and making sure we're sort of focusing on the centers that are less impacted or less likely to be impacted in a But it's going to be a topic we'll have to watch very carefully as we go through the second half of the year with the risk of having some kind of flu on top of COVID.

And there is an element of an ability to balance out.

And you know as you can imagine while we work you know a pretty heavily hit the New York City.

In the middle of again towards the end of April.

Now actually have enrolled quite a few patients out of New York. So so it's really kind of managing as asked the pandemic kind of flows frankly to the country, managing accordingly, and and making sure we're sort of focusing on the centers that are or less impacted or less likely to be impacted in a way that would it I'm actually put.

The agitation frankly at risk.

But it's going to be sinus guy be a topic will have to watch very carefully as we go through the second half the year, where they are the risk of having kind of a flu.

Fluent top off of Corbett and frankly, you know you know the people's attitude starting to Wayne.

Christian Martin Itin: And frankly, you know, people's attitudes are starting to wane. And, you know, people are starting to get fed up with where we are. And I think that aspect is probably one of the biggest risks that we're all going to be dealing with is that we keep our act together as a population. And, you know, depending where we are, we know we have, I think, our issues with actually doing that.

The you know people start to get fed up with wherever you are and I think that aspect is probably the biggest risks are all going to be dealing with is that we frankly keep our act together.

As a population.

And you know depending where we are we know we had I think our issues with actually doing that and that is actually I think where where the fundamental biggest risk is that we're dealing with.

Jim Bertineau: And that is actually, I think, where the fundamental biggest risk is that we're dealing with. Just one final question, Christian, and thanks for that. Just in terms of maybe moving your cell therapies up to earlier lines and away from less, you know, more from the brittle patients and in the salvage setting, can you maybe speak to that strategy to maybe move Auto-1 or Auto-1-NG or Auto-3 or Auto-3-NG up to earlier lines? What is the strategy there?

Your final question, Chris Gonna banker that just in terms of load moving your cell therapies up earlier lines and away from left or from the brittle.

Since then and the salvage setting they couldnt ready for that strategy that it does move out of one or out of one into your auto for your auto premiums is up to earlier lines. What the strategy is there.

I think it's a very it's a very important point.

Christian Martin Itin: I think it's a very important point. It's an area we're looking at very intently, and so we're looking at ways to, for early lines of therapy settings for ALDA3 and DLPCL, which we believe is important. And we're also looking at the opportunities in the ALL setting as well, where, you know, clearly, from the experience with Blinatumumab, going to an early line of therapy, basically, with that particular redirected T-cell therapy doubled the molecular CR rate by going earlier in the setting. So there's a very clear, very strong rationale for moving to an earlier setting and a very significant opportunity for improved outcomes at Also, they are less beaten up.

It's an area, we're looking at very intently and.

So we're looking at ways to for early lines of therapy settings for all the three and deal Bcl, which we believe it's important.

And the we're also looking at that Alsop the opportunities in the A.O.L. setting as well.

Were you know clearly we know from the experience with within a two AMAP I'm you know going to an earlier lines of therapy basically in that particular with that particular redirected T cell therapy doubled the molecular CR rate.

By going earlier in the in the setting so there's a very clear very strong rationale for moving to earlier setting and and a very significant opportunity for.

Improved outcomes that at a number of levels.

In these patients also less beaten up they have typically the disease isn't quite as fast as rapidly progressing as we have at the fat last line setting.

Jim Bertineau: They typically have the disease isn't quite as rapidly progressing as we have in the last line setting. And that actually, together, gives you an opportunity to have a much more profound impact on these patients. Great, thanks for taking the question. Thanks a lot, James. Our next question comes from Asthika Goonewardene from Truist. Hi, guys. Good morning and good afternoon.

And the and that actually together actually gives you an opportunity she has a much more profound impact for these patients.

Great. Thanks for taking the question.

Thanks lodging.

Our next question comes from she captain wording from Travis.

Hi, guys good morning, and good afternoon.

Asthika Sarith Goonewardene: Thanks for taking my question. I was wondering about Auto IV. Could you maybe talk to us a little bit about what we would expect from the data in the first half of 2021 and what kind of follow-up? And then also, if I can add on to that, T-cell lymphoma is a very diverse set of diseases. I was wondering if there's potential for you to get a broad indication across all T-cell lymphomas by focusing on the three subtypes that you're looking at in the phase one study? First of all, thanks for joining us, Asthika.

Taking my question I was wondering about auto for could you maybe talk to some little bit about what we would expect him to data into first half our 2021 and what kind of follow up and then also if I can add onto that T cell lymphoma is a very diverse set of diseases. I was wondering if there's potential for you get.

A broad indication across all T cell lymphoma by focusing on the three sub types that you look you haven't phase one study.

First of all thanks for joining our sticking on the deep deep order for overseas is it still in dose escalation. So it's going to be a smaller number of patients with dose escalation information and you know what we'll see whether where we are at that point in time in terms of the dose levels, but the information will be.

Christian Martin Itin: The Otto IV is obviously still in dose escalation, so there will be a smaller number of patients with dose escalation information, and we'll see where we are at that point in time in terms of the dose levels. But the information will predominantly be on the activity of the product at certain dose levels in a small number of patients. In terms of the disease setting, you're right, T cell lymphomas are quite heterogeneous in terms of the population. However, when you look at outcomes, the large settings actually have a very similar, rather homogeneous outcome.

Libbey on or you know deal.

Activity of the product that certain dose levels in a small number of patients.

In terms of the disease setting you're right T cell lymphomas are quite heterogeneous in terms of the population. However, when you look at outcomes.

The large settings actually has a very similarly, rather homogeneous outcome. So you can actually include the largest settings in a single trial and actually have on it as a single trial in that in there.

Christian Martin Itin: So you can actually include the largest settings in a single trial and actually run it as a single trial in that it actually has the same outlook in terms of a timeline with regard to relapses, duration of responses, et cetera, in general, where they behave very similarly. And that is what we're doing. So we're actually allowing the major indications in T cell lymphoma to be recruited into the study and have an indication like PTCL as a separate entity that would actually have to be developed as a separate label. Great, thank you. All right, thanks a lot.

That actually has the same outlook in terms of.

Timeline.

With regards to relapses.

Duration of response is et cetera in January the behave very similarly, and that is what we're doing so we're actually allow the major indications in T cell lymphoma would be recruited into the study and the and the and a half a a indication like PTCL as a separate entity that would actually have to be.

Developed as a separate label.

Great. Thank you.

All right. Thanks, a lot.

Our next question comes from Robert Andrew with William Blair.

Asthika Sarith Goonewardene: Thank you. Our next question comes from Robert Andrew with Williams. Hi there, this is Rob Andrew on behalf of Matt Phipps.

Hi.

This is Rob Undrawn Fips, that's taking my questions I'm just couple from me a note in the press release here that the manufacturing cost it's been a increase to the capital side is that it's not just in general to support the.

Robert F. Dolski: Thanks for taking our questions. Just a couple from me. I noticed in the press release here that the manufacturing capacity has been increased at the Caspel site. Is that just in general to support the, you know, pivotal for Auto 1 and the potential launch there, or is that also taking into consideration a potential Auto 3 launch as well? And then I guess given the number of candidates that are entering the clinic in the next kind of 6 to 12 months, you know, is the capacity there now able to support all those studies without strain, or does that have to be prioritized? Very good question.

You know that different pivots Ofer also won and the potential launch that or is that kind of also taking into consideration or potential also three launch as well.

I guess given that the number of the candidates that are entering the clinic in the next kind of 612 months, yes. The capacity there are now able to support although still needs without strain or orders out to be a prioritization.

Very good question, so we're adding capacity at the cell therapy catapult to actually support a launch for for auto one supporting launch for all the three you believe will actually acquire more capacity and that's one of the reasons why we're obviously working on the onto the Rockwell facility that we.

Christian Martin Itin: So, we're adding capacity at the South European Catapult to actually support a launch for Auto One. Supporting a launch for Auto Three, we believe, will actually require more capacity, and that's one of the reasons why we're obviously working on the Rockwell facility that we introduced a little while ago. With regard to the... capacity for the conduct of clinical studies.

We have introduced a.

A little while ago.

With regards to the.

Capacity for the conduct a clinical studies, obviously, we do have quite a bit of capacity at this point in terms of our ability to run clinical studies and Ah well with the capacity. We're building up also towards a commercial launch we'll actually have quite a good level of acts.

Christian Martin Itin: Obviously, we do have quite a bit of capacity at this point in terms of our ability to run clinical studies. And with the capacity we're building up also towards commercial launch, we'll actually have quite a good level of access to cell manufacturing capacity that we believe will not limit us with regard to clinical programs. I think also worthwhile mentioning in this context is that we're obviously also collaborating with academic centers on some of our programs, including Auto I, NG, and Auto VIII, where we're at the same types of processes that we run, our Auto I and Auto III programs, which are actually being run at GMP facilities at some of those academic partners as well. So we actually have quite a network of capacity that we can work with, particularly for early translational studies. Okay, great. And then if I just follow up on maybe an earlier question on the AutoAid program, you know, seeing that we're still on track for initiation in the second half year. Any kind of additional information on where we might hear some more about the design of the new cars that are in there?

Yes, two cell manufacturing capacity that we believe will not limit us a way the guards to the clinical programs I think also worth filings and mentioning in this context is that probably also collaborating with academic centers on some of our programs, including auto on NGL.

All the way where we're at the same types of prophecies process that we're running.

Auto loan and all the three programs.

Those are actually being run at a GMP facilities at some of those academic partners as well. So we're actually having quite a network of capacity. It we can work with particularly for the earlier translational studies.

Okay, Great and then if I just follow up on maybe another question I'm only up to eight program I'm, you're saying that we're still on track for each night initiation in second half year I'm any any kind of additional information on why we might yeah. Some more about the design of the new cars that are in that maybe any preclinical data that.

Christian Martin Itin: Maybe some preclinical data that kind of supports this advancement? I think for now, we're obviously working on, you know, publishing quite a bit of our data across our programs and AutoAid, but we're probably going to hold back a bit. We want to see kind of how the product actually behaves in the clinic.

Kind of supported this advancement.

I think for now well well obviously working on the you know publishing quite.

A bit of hard data across our programs and all the way, we're probably going to hold back a bit we want to see kind of where the product actually they have looks into clinic.

Christian Martin Itin: And then actually, we'll make the determination of when and how to present. This program is obviously in a very competitive space. And it also, frankly, has to hit a very significant biological hurdle that we set for the program. And so we'll want to actually run it out and see where we get to, and we'll update in due time. Great. Thank you. All right, thanks a lot.

And then actually will make this a determination of when and how to present on this program is obviously in a very competitive space and it's also frankly has to hit a very significant biological hurdle that we set for the program.

And so we want to actually run it out and see where we get too and we'll update in due time.

Great. Thank you.

Alright, Thanks, a lot.

Andrew Oakley: Thank you. Our next question comes from Greg Zubanin, A, from Goldstein. Hey, good morning and good afternoon. Thanks for taking my questions and congratulations on the progress that you're making. I have two questions, if I could.

Our next question comes from Graig Suvannavejh from Goldman Sachs.

Hey, good morning, and good afternoon, Thanks for taking my questions and congrats on the progress that you're making I had two questions. If I could the first it's just I'm not competitive landscape and we recently saw approvals for.

Greg Zubanin: The first is just on the competitive landscape, you know; we recently saw approvals for Manjuvi, which is in a second-line setting for DL-BCL, and Blenrep, which is a BCMA targeting asset and perhaps in a fifth-line setting for multiple myeloma. So, with that in mind, could you just remind us how you're thinking about Auto 3 and Auto 8, respectively, and how, you know, they are going to be positioned relative to those products? And then my second question is actually maybe best for Andrew.

My view, the which is you know in a second line setting for DLP, Seattle and blend wrap which has to be DNA targeting asset and perhaps in a fifth line setting for multiple myeloma. So just with that and mine could you just remind us how you're thinking about auto three and auto eight respectively and how are you know they.

Our gonna be positioned relative to those products and then my second question is actually not maybe best for for Andrew I'm, just thinking about as you advance.

Christian Martin Itin: I'm just thinking about, as you advance, particularly auto one, and you're getting closer to potential filing and, hopefully, commercialization, just trying to get a better sense of when, as a company, you guys are thinking about increasing investment around pre-commercialization activities or commercial infrastructure ahead of that. Thanks. All right. Well, thanks a lot for joining us, Greg. Thanks for the questions.

[noise], particularly our wine and you're getting closer to potential filing and hopefully commercialization just trying to get a better sense of when a company that are thinking about increasing investment around pre commercialization activities. Our commercial infrastructure ahead of that thanks.

All right well, thanks, a lot for joining Greg thanks for the questions.

Christian Martin Itin: So with regard to the competitive landscape, obviously, within the DLBCL segment, there are obviously quite a good number of programs that are active in the space. We had, as you pointed out, the recent approval of the CD19 monoclonal antibody from Mifrosis and Xencor. And but there is also obviously quite a wide range of activities with specific antibodies and ADCs, as well as obviously a range of different types of CAR T approaches. So it is absolutely a competitive environment.

So with regards to competitive landscape, obviously on the within the D.C.L. segment. The there was obviously I'm quite a good number of programs did or are active in the space or we had as you pointed out.

The recent approval of the Cdnineteen monoclonal antibody from a process and Xencor and Ah Ah, but there was also obviously quite a wide range of activities waste by specific antibodies ADCC has now there's obviously a range of a different types. This car T approaches so absolutely a competitive environment.

With regards to the Cdnineteen monoclonal antibody I think the attractive.

Christian Martin Itin: With regard to the CD19 monoclonal antibody, I think the attractive part about that program and the current setting is that it's a setting where the patients actually have a hard time tolerating significant adverse events. It's patients that are not eligible for an autotransplant. And what we basically need for these patients is a very well tolerated approach that still gives them an opportunity to actually get a longer-lasting remission in that particular setting. And that is really what the program managed to do, combined, obviously, with a rather mild chemotherapy component, which I think was the critical piece there to sort of create a therapeutic option for patients that otherwise would have a hard time taking on a lot of toxicity. So that is, I think, where that program is. When you look at the data and last line setting, the CRs actually come down dramatically.

Part about not program and declared the current setting you said, it's a it's you're setting where.

The patients actually have a hard time tolerating significant adverse events as patients that are not eligible for a and all the transplant and the end and board we basically need for these patients. These are very well tolerated approached it still gives them an opportunity to actually get a a longer lasting remission.

In that particular, setting and that is really what the program managed to do.

Combined obviously wayfair, yeah, rather than miles chemotherapy component, which I think withstood the critical piece there to sort of create a therapeutic option for patients that otherwise would have a hard time taken on a lot of toxicity.

So that is I think where that program is when you looked at the data and last line setting.

The the CR is actually come down dramatically and there maybe a 20% whether they are sustainable I think it's too early to tell.

Christian Martin Itin: And there may be a 20 percent. But whether they are sustainable, I think, is too early to tell. So they're very similar to other approaches that we've seen in the last line setting and where, in fact, the CAR T programs are set apart significantly. When you look at the just got the data, which is still to date the best long-term data that we have in DLDCO patients, which is around 37 percent, that is clearly substantially over and above any of the other therapeutic modalities currently being used. So I think that's important to keep in mind. What we see today with Auto3 is that we may be tracking above discard on long-term remissions, and we'll obviously need more data, and more follow-up to prove that.

So they're very similar to other approaches that we've seen in light last nine fitting in where in fact the car T programs are set apart significantly.

And when you look at the you know they just Carter data, which is still to date. The best long term data that we have in deal DCIO patients, which is around 37% bodies, clearly substantially over and above or any of the other therapeutic modalities currently being tested so I think that's important to keep in mind, what we see today with that order three.

Is that we may be tracking above just carton on long term remissions and we'll need to obviously have more data more follow up to prove that but the data today look very promising that we might be in good track to be a to actually demonstrated superior profile.

Christian Martin Itin: But the data today look very promising that we might be on good track to actually demonstrate a superior profile. So, from that perspective, I think that the landscape hasn't changed. I think there's a new component for patients that, you know, have limited ability to take toxicities, and I think that is important and it does matter, but it also is a setting where you could see CAR T actually move in as well and be highly active, certainly from the data that we've seen across the various lines of therapy and the obesity I would expect. On AutoAID, the BCMA-ADC is active.

So from that perspective, I think that landscape hasn't changed I think there's a new component for patients.

At the you know have limited ability to take toxicities.

And I think that is important and it doesn't matter, but it also setting where you could see carty actually moving as well and be highly highly active as well is where I would expect certainly from the data that we've seen across the various lines of therapy into you'll be sale would expect.

All right. The DCM 80 see exactly if there's no question about it it does by sometime but not an awful lot a time when we look at the is basically the data we see in the field in the car T side to be that bluebird or be it the changes program, particularly the JNJ program has very significant.

Christian Martin Itin: There's no question about it. It does buy some time, but not an awful lot of time. When we look at basically the data we see in the field on the CAR-T site, be that Bluebird or J&J, particularly the J&J program, has very significant, very deep molecular complete remissions, a very impressive data set, and substantially over and above, we believe, any of the other therapeutic modalities currently out there. And we'll have to see kind of where ADCs and other therapeutic modalities fit in So I think in that sense, the landscape hasn't changed in a significant way as far as from our perspective, and we still see, you know, very significant opportunities, unchanged, frankly, for CAR-T approaches with differentiated profiles in DL-BCL and multimodal. Andrew, do you want to take the second one?

And very deep more likely complete remissions very impressive data set.

And the substantially over and above we believe any of the other therapeutic modalities.

Currently out there.

And we'll have to see kind of where ultimately 80 season other therapeutic modalities fit in and how they're going to be slotted across the spectrum off of lines of therapy and also the opportunity to potentially combined with other therapeutic modalities as well.

I think that trends that landscape hasn't changed in a significant way as far from our perspective.

And we still see a you know very significant opportunity unchanged frankly for carty approaches with differentiated profile to deal PCL and multiply them.

Andrew you want to take the second one.

Yeah I do it's.

Andrew Oakley: Yeah, I do. Greg, thanks for the question. I mean, look, I mean, in terms of where we are talking about commercial, you know, sort of ramp up, etc. You know, that'll be a question I think we'll be addressing in 22. There's not a huge need at the moment for that.

Great. Thanks for the after the question I mean look I mean in terms of where we are talking about a commercial you know sort of ramp up et cetera.

You know thatll be a question I think we'll be addressing in 22.

I mean, there's there's not a huge need at the moment to that went very fortunate that we have.

Andrew Oakley: We're very fortunate that we have a very experienced, um, commercial group. It's a very small commercial group, but a very experienced commercial group, and so you know they they're providing all of the sort of the thinking and the input that we need at this point. The physical, sort of, you know, boots on the ground sort of thing. It is certainly a question that I'd be happy to talk to you about when we get to Thank you. All right, well, thank you all for joining us today. It's great to actually be able to give you an update. Great to see many of you joining the call in the middle of August or beginning of August here.

I'm very experienced.

Commercial group, it's very small commercial group at the very experienced commercial group and so you know they didn't body Golden State. There was some the thinking in the input that we need at this point.

The physical sort of you know boots on the grounds sort of thing is is certainly a question that I'd be happy to talk to you about in when we get to 2022.

Thank you very much.

Thank you.

Thank you so it looks like that's all the time that we have for questions. The company will be happy to take any follow up questions directly and I'll now turn you back over to Dr. Christian.

All right well. Thank you all for joining us today, Oh, great to actually be able to give you an update I'm a great to see many of you joining the call in the middle of August or beginning of August here.

Andrew Oakley: So we're looking forward to the end of the quarter and updating you on all those three, and then obviously at the end of the year at ASH for the additional updates on both of our HEMON programs in B-cell malignancies. With that, thanks a lot for your continued support, and looking forward to obviously being in touch and keeping you updated. Thanks a lot. Goodbye.

So we're looking forward to the ended the quarter and update you. Another three and then obviously at the end of the year at Ash for the additional updates on both around him on programs, a and b cell malignancies with that thanks, a lot for your continued support and looking forward to Oh see being a touch and keeping you updated thanks a lot the bye.