Q2 2021 Autolus Therapeutics PLC Earnings Call

[music].

Today's conference is scheduled to begin shortly please continue to standby. Thank you for your patience.

[music].

Hello, Ladies and gentlemen, and welcome to the auto loss of Therapeutics second quarter of 2021 financial results conference call and.

And as a reminder of this conference call is being recorded.

Operator: Thank you for your patience.

Operator: ??? ??? © BF-WATCH TV 2021

Operator: Hello, ladies and gentlemen, and welcome to the Autolus Therapeutics Second Quarter 2021 Financial Results Conference Call. As a reminder, this conference call is being recorded. I would now like to turn the call over to your host, Dr. Lucinda Crabtree, Vice President, Business Strategy. Please go ahead.

Lucinda Crabtree: Good morning or good afternoon, everyone, and thank you for staying. I am Lucinda Crabtree, Vice-President of Business Planning and Strategy. With me today are Dr. Christian Itin, our Chief Executive Officer, and Andrew O'Brien. Before we begin, I would like to remind you that during today's call, our discussion will contain forward-looking statements. All statements, other than statements of historical facts, on this call are forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the section titled Risk Factors in our annual report on Form 20-F filed with the Securities and Exchange Commission on March 4, 2021, which can be accessed on the EDGAR database at www.sec.gov and in subsequent filings that we make with the SEC from time to time.

Okay. So even if the company sees change the.

Forward looking statements should not be relied upon as representing the company to use as of any day subsequent to today.

Lucinda Crabtree: The forward-looking statements on this call reflect the company's views as of today, August 5th, 2021, regarding future events and should not be relied upon as representing the speakers or the company's views as of any subsequent date. While the company may elect to update these forward-looking statements at some future point, it specifically disclaims any obligation to do so, even if the company's views change. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to today.

Piece of advice that today's call is being recorded and wet cough.

So on slide 3 and we'll see the agenda for today and it tastes. The scholars Christian will provided the brief introduction and that will be calling my original highlights for the second quarter of 2021.

And she will discuss the company's financial results on the <unk>.

And then Christian will conclude without coming Holstein and any other Cleveland and.

Lucinda Crabtree: Please be advised that today's call is being recorded and webcast. So, on slide three, you will see the agenda for today, and it is as follows. Christian will provide a brief introduction, and that will be followed by optional highlights for the second quarter of 2021. Andrew will discuss the company's financial results, and then Christian will conclude with upcoming milestones and any 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. Thank you.

And of course, we will welcome your questions from the now remarks so.

So with that I'd like to turn the call. It I just Christian thank you.

Thank you Lucy and and welcome everybody to our second quarter total.

First off I'd like to briefly go back through kind of where we started also of the queue on call, which is half of a quick look at the state of the covered epidemic that we're going through and the impact of it will have or has on our business. As you May remember, we did guide and and Q1 of that we were hopeful that by the middle of the year we were.

Christian Martin Itin: Thank you, Lucy, and welcome everybody to our second quarter call. First off, I'd like to briefly go back to kind of where we started also the Q1 call, which is have a quick look at the state of the COVID epidemic that we're going through and the impact it will have or has on our business. As you may remember, we did guide in Q1 that we were hopeful that by the middle of the year we should reach a level of stabilisation due to increased levels of vaccination, but also a substantial number of people actually having recovered from COVID infection, that we should get into an overall more stable environment so that the fluctuations that we see in terms of the cycles of COVID or the waves of COVID should actually start to ebb up and get us to a place where we have overall more stability and a more predictable environment for our patients that we're obviously enrolling into our trials.

Should reach the level of stabilization due to increased levels of vaccination, but also a substantial number of people actually having recovered from covered infection that we should get into and overall more stable environment. So that the fluctuations that.

We'll see in terms of the cycles of coverage of the waste of college should actually start to add up.

To just add and get us to a place where we have overall more stability and the more predictable the environment for our patients that were obviously enrolling and 2 other trials and we also big guys that were expecting to be able to actually ramp up enrollment by middle of this year.

We're very pleased to say that indeed, what we were hoping for the actually is the reality today I think we do have reached now.

Between the vaccinated people as well as people who've ricard from infection as a level of about 70% in the U S. At the same actually and the U K and that gives us actually a base level of stability that I think is very helpful. In terms of the conduct of the clinical studies and now we obviously all have seen the impact of the day also of area and.

Christian Martin Itin: And we also did guide that we're expecting to be able to actually ramp up enrolment by the middle of this year. We're very pleased to say that indeed what we were hoping for is a reality today. I think we do have a reach now between vaccinated people as well as people who've recovered from infection at a level of about 70% in the US and the same actually in the UK. And that gives us actually a baseline level of stability that I think is very helpful in terms of the conduct of the clinical studies.

But we also do see very nicely that indeed, the while the walls. There are searches and certain places that in fact, they seem to be curved much March more quickly than what we had seen earlier and the ear and I think on a nice reflection of the fact that the vaccines are doing actually a great job and I'm Gonna P. R.

S. As we were hoping that also actually did allow us to increase and vamp off the and what women ready and 2 hour trials and obviously this is obviously very good news and I think I will allow us to actually keep on track and on on the timelines that we have we're giving where the college Cherokee studies, if we go to.

Christian Martin Itin: Now, we obviously all have seen the impact of the Delta variant, but we also do see very nicely that, indeed, while there are surges in certain places, that they seem to be curbed much more quickly than what we had seen earlier in the year. And I think that is a nice reflection of the fact that the vaccines are doing a great job and we are.

Slight number 5.

Quick update on the just the key activities on the pipeline first off of obviously the activities on <unk> on her Felix study, it's progressing well and reiterating our guidance of pivotal data that will load the labor during the course of next year and.

Christian Martin Itin: Well, you know, as we were hoping, that also allowed us to increase and ramp up the enrolment rate into our trials. And obviously, this is obviously very good news and I think will allow us to keep on track and on the timelines that we were given with regard to our key studies. If we go to slide number five, a quick update on just the key activities in the pipeline. First off, obviously, are the activities on OVCell.

No and this quarter, we have an opportunity to update additional experiences with it would be so impatient and not only and and ALLL, but also in and non hodgkins lymphoma, and a and now we were able to actually look at it and have a quiet extend it.

Christian Martin Itin: Our Felix study is progressing well, and we're reiterating our guidance for pivotal data that we will deliver during the course of next year. Now, in this quarter, we have an opportunity to update additional experiences with OBCell in patients, not only in ALL but also in non-Hodgkin's lymphoma. In ALL, we were able to actually look at now a quite extended observation time of the patients of now more than two years. And what we were able to see is that, indeed, event-free survival in this trial actually was stabilizing at 12 months, just above 50%, and actually that level was sustained over 24 months.

Observation time off the patients of no more than 2 years and what we were able to see is that indeed the of entry survival of and in this trial actually was stabilizing of 12 months, just about 50 per cent and actually that level was sustained over 24 months. This is very good news because it really gives.

Is this the first clear and that indeed, we may have a transformational therapy for these patient population and frankly uhm, a suggestive of a durable effect and at least a subset of the patients that we've been treating so that's obviously very good news, it's not of the data starts to actually <unk>.

Sure to a point, where I think and.

Christian Martin Itin: This is very good news because it really gives us the first clear hint that, indeed, we may have a transformational therapy for this patient population and is, frankly, suggestingive of a durable effect in at least a subset of the patients that we've been treating. So that's obviously very good news. It's now the data starts to actually mature to a point where I think the data actually has a level of validity that really matters in terms of our own view as well as of the program. In addition, we also obviously did look at or did present data on patients with Non-Hodgkin's lymphoma, particularly follicular lymphoma, and mantle cell lymphoma, and were able to show very high levels

The the day to actually has a level of of the lately that really matters in terms of our own view as well off the program.

The the in addition, we also obviously did look or day present data on patients with non Hodgkins lymphoma particular, follicular lymphoma, non it'll sell and pull them out and were able to show very high levels Uhm off metabolic see alright, and Faq old patients the chief Metapolitics the ours.

And also combined with a very good safety profile.

Now in addition to I would say that key day to update the D. H, a but also had a publication and nature of cancer looking at some of the product features that may be associated with this longer ability of the fact that we're starting to see and D. M L patients.

Christian Martin Itin: In fact, all patients achieved metabolic CRs and this was combined with a very good safety profile. Now, in addition to that key data update, the DHA, we also had a publication in Nature Cancer looking at some of the product features that may be associated with this long durability of effect that we're starting to see in DLL patients. Now, moving to the regulatory side, I think the two key events that were happening in the second quarter.

Now moving to the regulatory side I think the 2 key events that are happening and and the second for the first we did receive the so-called prime designation from Europe, and European Medicines agency, which way to give us and and the ability for the preferred engagement with the the key regulatory body.

The in Europe, and and which would be very helpful and the actual review process for the program as we're moving this program through the pivotal stage and and then further towards towards the the <unk>.

Christian Martin Itin: First, we did receive a so-called prime designation from the European Medicines Agency, which really gave us an ability to have preferred engagement with the key regulatory body in Europe and which should be very helpful in the actual review process for the program as we're moving this program through the pivotal stage and then further towards approval. When we look into the second designation that we did receive, the so-called ILAP designation from the UK Medicines and Healthcare Agency, MHRA, and what we did, and what that allows us to do, is quite similarly to the prime designation; it gives you preferred access to the regulatory body, but it actually goes beyond that.

When we look into the the second designation that we did receive from the so-called Eyelab designation from the U K medicines and health care agency and a chunk of Hay and what we did actually on what that allows us to do is quite similar late to the prime designation. It gives you.

The preferred access to the regulatory body, but it actually goes beyond that it also actually allows you to engage with the National Health service as well as with with nice and gives you a and ability to really approach with innovative therapies and the the key players in the UK that and.

Not only actually get you through the regulatory process, but also frankly ultimately to the patients.

So those developments, we believe actually are very important because it gives us the very good projection and the past that we can take with the program and are a reflection all of the day, though that we all the sleeper and able to generate so far.

Christian Martin Itin: It also allows you to engage with the National Health Service as well as with NICE and gives you an ability to really approach with innovative therapies the key players in the UK that will not only get you through the regulatory process but also, frankly, ultimately help the patient.

And as I said and indicated initially also were reiterating out of of guidance 2 half of the pivotal data during the course of 2022, 2 as we have the guy that before.

Christian Martin Itin: So those developments are very important because they give us a very good projection and a path that we can take with the program and are a reflection of the data that we have obviously been able to generate so far. As I indicated initially, also reiterating our guidance to have the pivotal data during the course of 2022 as we have guided. As indicated, the ob-cell data on relapsed refractory is obviously very encouraging, and I think that gives us, obviously, an opportunity for additional data flowing later in the year.

As indicated the <unk> date on the Lapstrake factory. Obviously is is very encouraging uhm and I think that gives and she'll just be an opportunity for additional data flow and like part of the of the here and finally on auto for we did also receive and Eyelock designation from the and H R. A again and giving us that preferred acts.

Yes that we're gonna use like the helpful to the program going forward.

Moving through slight fix just a quick update on the on the corporate side first off we had sold the bag 2 million a D. S. S. Under the open markets and sales agreement and during the course of the quarter, which net it 14.3 million and additional capital into the <unk>.

Christian Martin Itin: And finally, on Auto IV, we did also receive an ILAP designation from the MHRA, again giving us that preferred access that we believe will be helpful to the program going forward. Moving to slide six. Just a quick update on the corporate side. First off, we sold about $2 million of ADSS under the Open Markets and Sales Agreement during the course of the quarter, which netted $14.3 million in additional capital into the company. We had a change in the chairman role. Martin Murphy has taken over as non-executive chairman during the course of the quarter.

Company, we had a change of the chairman role Mark Murphy has taken over as non-executive chairman during the course of the quarter and we will look at the post period updates the very excited too and and and actually that happened just in July and out of the appointment of the Doctor After Bradley, who and has chewed.

And us as the new Chief Development Officer of the company F car has a tremendous amount of development experience in in the range of companies, including all 3 of a very long stay and very significant levels of activities that he had in the context of no marcus's on the D organization as well.

Christian Martin Itin: When we look at the post-period updates, I'm very excited to announce, and this happened just in July now, the appointment of Dr. Edgar Braendle, who has joined us as the new chief development officer of the company. Edgar has a tremendous amount of development experience in a range of companies, including a very long stay and very significant levels of activities that he had in the context of Novartis' L&D organization as well.

In addition was from broker joined us as the new head of clinical development well from joined US from My first day square. He was running claimed the clinical programs and particularly focused obviously on the non droopy program or if the system App program that was recently on.

The improved and the subset the ask if he was the large piece of lymphoma patients.

Christian Martin Itin: In addition, Wolfram Brucker joined us as the new head of clinical development. Wolfram joined us from Morphosis, where he was running the clinical programs and particularly focused, obviously, on the Monjuby program or Kefacitamab program that was recently, obviously, improved in a subset of diffuse large-B cell information. And then finally, we did announce early in the week an option and licensing agreement with Moderna. Actually, it's kind of a nice recognition of the technology base that we've developed at the company. This isn't particularly related to our capabilities of engineering binders with very unique properties.

And then finally, we did and answer early in the week.

And option of advice and agreement with Moderna actually where kind of of nice recognition of the the technology based at least develop that the company the Susan particularly related to our capabilities of engineering binders with very unique properties and and types of binders are.

Consider it to be used obviously in in the context of the art and a approaches platform approaches the motor and and I was working on.

Uhm, so with that I think we're good to move to slide number 7.

And what I'd like to do is to switch gears briefly reset I sort of out of its faults, where the guards to a O L and if you remember all of a side of a key focuses on delivering the Felix study and adult patients with relapsed refractory a O L.

Which includes patients that are <unk>.

Of a post plain of 2 of them at as well as inner tubes of map, but as well as patients that actually artist and that really upsetting but have no idea of experienced in the Tuesday map orpiment net to the map. So we have to stop populations that we're actually looking at the in this particular trial and S. Which is mentioned we're exploring the activity of the.

Christian Martin Itin: And those types of binders are considered to be used obviously in the context of the RNA approaches, platform approaches that Moderna is working on. So with that, I think we're good to move to slide number seven. And what I'd like to do is just switch gears, briefly reset our thoughts with regard to ALL.

Christian Martin Itin: As you remember, obviously, our key focus is on delivering the FELIX study in adult patients with relapsed refractory ALL, which includes patients that are both post-blenotumumab as well as inotuzumab, but as well as patients that actually are just in a relapsed setting but have not yet experienced inotuzumab or blenotumumab. So we have two sub As we just mentioned, we're exploring the activity of the OB-FEL program and beyond ALL, and we do that in the context of the old CAR-19 study with additional cohorts.

The program of Obi sell them beyond a O L and we do that and the context of the old car and 19 study with additional cohorts and in addition to the data that we just released on the first Follicular mental Saltation. We will also actually include patients with the L. D. C. On let's see on L and will are planning for additional update towards the.

The end of the year, and then add a and the evolution of the Oh the sale of all the 1 program, where no actually treating children with an older 122, which is building on the the older 1 of our O b cell of backbone, but as a novel see the 22 <unk> Beach and receptor.

Christian Martin Itin: And in addition to the data that we just released on the first follicular mantle cell patients, we will also actually include patients with DLD-CELL and CLL, and we are planning for an additional update towards the end of the year. And then, as an evolution of the OB-CELL or Auto-1 program, we are now actually treating children with Auto-1-22, which is building on the Auto-1 or OB-CELL backbone but adds a novel CD22 chimeric antigen receptor where we're evaluating that product in pediatric patients with ALL.

And when and where are we evaluate the product in pediatric patients with a O L.

So with that I'd like to move to slide number 8 and and on slide on bright and it's just some of the key see I think features that are important with regards to a O L. As an indication and the the standard and status of care that we currently see and be syndication.

The first off.

I think it's important to realize the particularly on the and the adult population with a L. L. Only a smaller percentage of the patients actually have and ability to achieve of long term benefit the looking at somewhere between 30 to 40 per cent of the patients business. Despite the fact that most of the other patients about 90 per cent actually.

Christian Martin Itin: So with that, I'd like to move to slide number eight. And on slide number eight, it's just some of the key features that are important with regard to ALL as an indication and the standard and status of care that we currently see in this indication. First off.

Will the chief of complete information and for and frontline therapy. However for most of these patients that complete your mission and actually does not translate into of long term information.

Christian Martin Itin: I think it's important to realize that, particularly in the adult population with ALL, only a smaller percentage of the patients actually have the ability to achieve a long-term benefit. We're looking at somewhere between 30 to 40 percent of the patients. This is despite the fact that most of the patients, about 90 percent, actually will achieve a complete remission during frontline therapy. However, for most of these patients, that complete remission actually does not translate into a long-term remission.

So when patients do relapse. After you obviously haven't gone through a very intense high dose chemotherapy and adoption and the consultation after day get through that and eventually relapse. Many of them would actually go on the additional cycles of high <unk> high dose chemotherapy, followed by stem cell transplant. However, although the.

Is it a certain chance of cure with the stem cell transplant still the majority of the patients getting onto the transplant will actually be maps again and.

Christian Martin Itin: So when patients do relapse after obviously having gone through very intense high-dose chemotherapy, induction, and then consolidation, after they get through that and eventually relapse, many of them would actually go on additional cycles of high-dose chemotherapy followed by a stem cell transplant. However, although there is a certain chance of cure with the stem cell transplant, still, the majority of the patients getting on to transplant will actually relapse again. And that gets us to the patient population that's really in a very, very difficult spot with a very, very limited amount of time that, indeed, on average, these patients still have available.

And that gets us to the patient population of sweet and a very very difficult spot with a very very limited time that the indeed the on average these patients still have available.

And what we are currently working and went looking at in this field is that the the the standard of care of particularly and the you asked is really starting to concentrate on blend of 2 of <unk>, we see of 60% or so of the patients receive and glenda to the map into the U S. However, although opening of 2 and that is active and.

And it does not actually convey longterm and insurance in the patients and the relapsed refractory setting.

Christian Martin Itin: What we are currently looking at in this field is that the standard of care, particularly in the U.S., is really starting to concentrate on Blinitumumab. We see about 60% or so of the patients receiving Blinitumumab in the U.S. However, although Blinitumumab is active, it does not actually convey long-term remissions in patients in the relapsed refractory setting. So, when we then look on the CAR-T side, I think, obviously, a very challenging start that we have seen CAR-T approaches in general getting into the adult population in ALL with a lot of challenges managing the adverse events that were actually induced by the therapy itself And we're now at a point where, obviously, we're starting to see search programs move.

So when we didn't look on the car T side, I think obviously, a very challenging start that we have seen the khaki approaches and generally I getting into the adult population and a and L. With the a lot of challenging the managing actually the adverse events that were induced by the therapy itself and.

And we're now at the point, where obviously, we're starting to see the first programs moving with the leaf that we have the highly attractive set of properties with on the program and all of a <unk>. There is a an opportunity when we think about the progression of the positioning of of the product to ultimately move this type of therapy up the line where ever believe it's actually the the.

This place from her benefit risk of perspective that I think that we can get with this type of of therapy. We just talked about the fact that we did receive all with the the state of regulatory designations.

Christian Martin Itin: We believe that we have a highly attractive set of properties with our program, and obviously, there is an opportunity, when we think about the progression and the positioning of the product, to ultimately move this type of therapy up the line, where we believe it's actually the best place from a benefit-risk perspective that I think that we can get with this type of therapy. We just talked about the fact that we did receive, obviously, a set of regulatory designations. Slide number nine.

Alright number 9 T update that we presented the D. H a is really around the event free survival. We already have communicated obviously that we have very high levels of respond face that we have a good safety profile, but what we're seeing now is as we're seeing looking at this and then free survivalist of indeed, the curfew stabilizing over time and that gave us.

Gifts is actually a very good sense did indeed, we have the chance of getting the proportion of these patients into longterm of nations.

Christian Martin Itin: The key update that we presented at EHA is really around event-free survival. We already communicated, obviously, that we have very high levels of responses, that we have a good safety profile. But what we're seeing now, as we're seeing, looking at this event-free survival, is that, indeed, that curve is stabilizing over time.

Moving too slight and on the 10, I think I want to make the point that the fact that we do see the stabilization of the day free survival of 2 hour and knowledge hasn't been shown before and this disease setting and.

And he's actually correlated with the exceptional persistence that we're seeing with the product not only do we see about of tenfold uhm increase and the maximum number of car T cells of happening reported and other programs, but we also are able to actually maintain and the level of car T cells over time.

Christian Martin Itin: And that gives us, actually, a very good sense that, indeed, we have a chance of getting a proportion of these patients into long-term. Moving to slide number 10, I think I want to make the point that the fact that we do see this stabilization of event-free survival, which to our knowledge hasn't been shown before in this disease setting, is actually correlated with the exceptional persistence that we're seeing with the product. Not only do we see about a tenfold increase in the maximal number of CAR T-cells that have been reported in other programs, but we are also able to maintain the level of CAR T-cells over time.

And will belief that that is actually a prerequisite to be able to actually translate a molecular responds into a longterm information and clearly the data from the whole car Stephanie are quite unique both and the the the actual absolute of Manhattan of car T cells formed in the patients which is indeed.

Christian Martin Itin: And we believe that that is actually a prerequisite to be able to actually translate a molecular response into a long-term remission. And clearly, the data from the Olkar study are quite unique, both in the actual absolute amount of CAR T-cells formed in the patient, which is, as indicated, about tenfold over other programs, but also the sustained level of CAR T-cells over time. On the right-hand side, you see basically the adverse event profile as we had reported it earlier.

Okay to the back tenfold over of all of the other programs, but it's also the sustained level of car T sales over time on the right time and I do see basically the the adverse event profile and asked me have reported it earlier I think what's important is obviously, we haven't seen high credit card of <unk> syndrome, and relate it to that and.

And you look actually the treatment that was used to sort of manage the adverse events related to the khaki therapy quite often you see with khaki therapies the need for base of presser's to stabilize the patients and it's important to note that none of the patients received space oppressors and and what that also.

Christian Martin Itin: I think what's important is that, obviously, we haven't seen high-grade cytokine belief syndrome. And related to that, when you look actually at the treatment that was used to sort of manage the adverse events related to the CAR-T therapy, quite often you see with CAR-T therapies the need for vasopressors to stabilize the patients, and it's important to note that, And what that also tells you is that these patients didn't actually have to go into the ICU to be managed.

<unk> is that these patients didn't actually have to go into the iced tea you to the managed so it's a very good safety profile, it's very well and manageable and it gives us a very unique I think is the profile.

Moving through slight number 11. This is just a quick look at some of the date of that we've seen that we need the space. We have obviously the date of fetch the birth of foundation and for the approval swiftly and of 2 and that the need of Tuesday map and we also know half and ask presented at <unk> and and published as well right at the same time.

Christian Martin Itin: So it's a very good safety profile, it's very well managed, and it gives us a very unique efficacy profile. Moving to slide number 11. This is just a quick look at some of the data that we see now in the space.

The data from the card is also in that and in the Master of factory. It all day and they'll also the basis of of the L. A finding and that the company and 8 so when we look at the overall that the state of sets. We do see that of the date out from <unk> does stack up very well against all of these pro.

Christian Martin Itin: We have, obviously, the data sets that were the foundation for the approvals for Blinituzumab and Linituzumab. And we also now have, as presented at ASCO and then published as well, right at the same time, the data from Picardus, also in relapsed refractory adult ALL, also the basis of a BLA filing that the company made. So when we look overall at these data sets, we do see that the data from OVCell does stack up very well against all of these programs.

The branch and certainly when it comes to safety as well as to the longterm impact the sea of entry survival that we have a very advantageous and then free survival of profile, which we believe will actually gave us over on a very nice day differentiated.

Product and this and the space.

Moving too slight number 12th and.

<unk> I didn't mention before I would say of the Felix study. This study is about at the Hunter on and 100 patient study well that's refractory patients has indicated and 2 subpopulations that we're looking at relapsed refractory post exposure to play and and over in the choosing that that's where all the patients who are.

Christian Martin Itin: And certainly when it comes to safety, as well as to the long-term impact we see of end-free survival, that we have a very advantageous event-free survival profile, which we believe will actually give us, overall, a very nicely differentiated product in this. Moving to slide number 12, I did mention before, obviously, the FELIX study.

Inexperienced with regards to play and Oh and the choose the map.

Uhm the primary and point of the study is all go of complete response rate.

And the secondary and points include molecular responses and as well as of the entry survival activation of response.

Christian Martin Itin: This study is about a 100-patient study, relapsed refractory patients, as indicated by the subpopulations that we're looking at, relapsed refractory post-exposure to Blina and or inotuzumab, as well as patients who are inexperienced with regard to Blina or inotuzumab. The primary endpoint of the study is overall complete response rate, and the secondary A quick word on the data that I referenced before in the non-Hodgkin's lymphoma patients.

Uhm quick word on to the data that I referenced before and the email on Hodgkins lymphoma patients. This is of swing plop of the 9 patients that were dose and were the subject of the presentation at the H a I should can see all of these patients of chiefs a metabolic complete the remake.

<unk>.

Uhm the safety profile of Rosemary Paul today's nobody had high grade Crs, none of the patients experienced any form of neurotoxicity.

1 of the patients Unfortunately actually contracted called it and the and diet as a consequence of call. It the patient died and and and metabolic complete remission.

Christian Martin Itin: This is a SWIM plot of the nine patients that were dosed and were the subject of the presentation at EHA. As you can see, all of these patients achieved a complete metabolic remission. The safety profile was very positive. Nobody had a high-grade CRS, and none of the patients experienced any form of neurotoxicity.

And which was a very sad event is what last on patient who developed a leash and in the scheme, which could be basically removed surgically, but obviously on that <unk> is and and.

Christian Martin Itin: One of the patients, unfortunately, actually contracted COVID and died as a consequence of COVID. The patient died in metabolic complete remission, which was a very sad event, as well as one patient who developed a lesion in the skin which could be basically removed surgically, but obviously that lesion is an event, a progression event in that patient and will have to be recorded. Now, slide number 14, just a quick word on the activities ongoing now that sort of actually round out the exploration of the activity of OBCell across a range of indications.

The progression of the anything that patients and.

And we'll have to be recorded that way.

No slight number 14, just a quick word on the activities ongoing that that sort of actually ran debt. The exploration of the activity of Oh, the cell across the range of the indications as I indicated to you before we do value 8 the activity in non hodgkins lymphoma patients as well.

Let's see a lot of patients as part of the extension of the old car 19 study. We're also conducting a and collaboration with our academic partners. The Carousel study, which is a study and patients that have primary C. N S lymphoma, which is an S and and.

Christian Martin Itin: As I indicated to you before, we are evaluating the activity in non-Hodgkin's lymphoma patients as well as CLL patients as part of the extension of the OLCAR-19 study. We're also conducting, in collaboration with our academic partners, the CARO-Cell study, which is a study in patients that have primary CNS lymphoma, which is, in essence, an aggressive lymphoma similar to DLBCL that is exclusively localized in the brain.

The aggressive lymphoma similar to the L. D C. L that is exclusively localized and the brain.

And then as already mentioned, we're conducting a extension of of the Cartel study with all of the 122 and pediatric patients Uhm and the obviously all of these programs will give us a very good overview over the range of activity that we see across the.

The range of C. D 19 positive malignancies.

Christian Martin Itin: And then, as already mentioned, we're conducting an extension of the CAR-CALS study with auto-122 in pediatric ALL patients. And obviously, all of these programs will give us a very good overview of the range of activity that we see across the range of CD19-positive malignancies. Moving to slide 15, on the T-cell Informa side, we continue to dose escalate the Auto4 program. We expect the data will be, and the first update on the data will be in the first half of 2022, and we'll provide that update, obviously, at one of the conferences in the first part of next year.

Moving to slide 15 on the T cell and for my side the continue to dose escalate. The all the 4 program and we expect the the data will be the first update on the day that will be and the first half of 2022 and.

And we'll provide that off the eighth obviously add 1 of the conference's and the first part of next year and alongside the progress on the old of 4 program. We're also going the time. The study entry for the older of Phys program, which we expect to occur and the same period of time.

And on Slide 16, just a quick reminder, that the company has a very strong technology base with probably 1 of the largest ipsa's uhm and in the business and blood you. Obviously did see on the matter and a side ace that the aspect of this technology and I used in the different setting this.

Christian Martin Itin: And alongside the progress on the Auto4 program, we're also going to time the study entry for the Auto5 program, which we expect to occur in the same period. Now, on slide 16, just a quick reminder that the company has a very strong technology base with probably one of the largest IP estates in the business. And what you obviously did see on the Moderna side is that aspects of this technology are now used in a different setting.

And I have all the city the case of of the modern of collaboration related to bite of technology that is all the Sri wanted the key elements that were using and a line of products as 1 of the.

Key elements of differentiation and you do remember that all of the state <unk>. The key feature and <unk>. There's a very unique type of the binder with a very unique set of properties, which really gives us that differentiated overall clinical outcome both of an effect to see on persistence, but also on safety.

Christian Martin Itin: This is now obviously the case of the Moderna collaboration related to binder technology. That is obviously one of the key elements that we use in all our products as one of the key elements of differentiation. And you do remember that obviously, the key feature of ob-cell is a very unique type of binder with a very unique set of properties, which really gives us that differentiated overall clinical outcome, both in efficacy, in persistence, but also in safety.

Now moving to fly 17, so the broad of program here all the straight I indicated already the or the 122 and all of the 5 program or the 6 and G. Uhm is moving forward would expect to be able to have and academic trial up and running with this.

Quite advanced programs product and the early part of 2022, and then all of a <unk> asked me I got it before all of the wait is and obviously the claim makes the this half of 21 and and we're preparing and also the auto 7 program.

Christian Martin Itin: Now moving to slide 17. So the broader program here, obviously, I have indicated the Auto 1.22 and Auto 5 programs. Auto 6 NG is moving forward. We expect to be able to have an academic trial up and running with this quite advanced programmed product in the early part of 2022. And then obviously, as we've guided before, Auto 8 is obviously in the clinics this half of 21, and we're also preparing Auto 7. Now, with that, I'd like to actually hand over to Andrew, who will lead you through our financial results. Thank you. Thanks Christian, and good morning or good afternoon to everyone.

Now with that I'd like to actually hand over to Andrew who will lead you to the financial results. Thank you.

Oh, Thanks Christian on the good morning, or good often and for everyone and things we can move to slide 19, It's my pleasure to review L financial results for the second order.

The <unk> so the 2021.

So the starting with the cash position cash and cash equivalents at the 30th of June total $216.4 million as compared to $279 million at the end of the first quoted March.

Andrew O'brien: I think we can move to slide 19. It's my pleasure to review our financial results for the second quarter to June 30, 2021. So starting with our cash position, cash and cash equivalents at the 30th of June totaled $216.4 million as compared to $239 million at the end of the first quarter. Worth noting that during the three months ending 30th June 2021, the company issued an aggregate of $2,069,466 ADSes under the ATM program for net proceeds after underwriting discounts and offering expenses of $14.3 million. Turn to the P&L.

Worth, noting the during the 3 months and being 30th of June 20th 21. The company issued an aggregate of 2.069 million 466 idea says on the the a T M.

Andrew O'brien: Total net operating expenses for the three months ending 30th June 2021 were $37.7 million. This is net of grant income and licensed revenues of $1.6 million. So you'll see that there and up front from the Moderna collaboration.

Andrew O'brien: This compared to net operating expenses of $39.5 million and net grant income of just $300,000 for the same period in 2020. Research and development expenses increased to $32.1 million this quarter, compared to $31.3 million for the same period last year. It's worth noting that cash costs, which exclude depreciation and amortization, as well as share-based comp, increased to $29.2 million from $26.5 million. Overall, the increase in R&D cash costs of $2.7 million consisted primarily of an increase in compensation and employment-related costs of $.7 million, which includes some of the severance payments.

The program submit proceeds off the on driving this accounts and offering expenses of $14.3 million.

Put it into the piano net operating total net operating expenses for the 3 months of <unk> 2021 was $37.7 million. This is next of granting come on the license revenues of $1.6 million, So you'll say the and upfront from from the the day.

And a collaboration.

<unk> list and paid to <unk> operating expenses of $39.5 million myth of got onto your account.

It just sort of $100000 for the same period and 2020.

The research and development expenses and close to $32.1 million this quota.

Compared to $31.3 million for the same period last year, it's worth, noting the cash costs, which exclude depreciation and and as <unk> as well as the shape is calm increase the 29.2 million from $26.5 million. Other all these increasing the and and on it and day cash cost of chicken.

$7 million consisted primarily of and increasing the compensation and unemployment related costs of the 0.7, which and claim some of the severance payments the the.

And the reduction and work force that we undertook and the first quarter of the <unk> and that was upset but and reduction and employment <unk> I'll just need you to decrease in the in the head comes from the program.

Secondly, and increase of $1 million and facilities tosses related to continue to sort of the scheduling of the manufacturing operations thirdly, and increase of zero point $9 million related to sort of materials consumed and the manufacturing process and and the labs and.

Andrew O'brien: and the Reduction in Workforce that we undertook in the first quarter of 2020.

Andrew O'brien: of this year, and that was offset by a reduction in employment costs, obviously due to a decrease in the headcount from the program. Secondly, an increase of $1 million in facilities costs related to continued scaling of the manufacturing operations. Thirdly, an increase of $0.9 million related to materials consumed in the manufacturing process and in the labs. Fourthly, an increase of 300,000 related to cell logistics, and an increase of 300,000 related to IT infrastructure and support. Burp, If we move to looking at non-cash costs, they decreased to $2.9 million for the year, for the three months ending 30th June 2021, from $4.8 million for the same period last year.

Hopefully increase of of 300000 related to sell logistics Uhm and an increase of 300000 related to on T infrastructure and support.

The move to looking at non-cash costs that'd be close to $2.9 million for the cause of the 3 months and the 30th June 2021 from 4.8 million for the same period last year and the day cases, primarily related to a shake and I just can't expense of which decreased but she put the industry yourself to the level of.

Value of the stock options combined with the forfeitures of of of options and on based on our shoes related to.

Those employees the <unk>.

Perfect affected by the reduction and what force and this is off the slightly bun increase and depreciation of of $900000.

General and administrative expenses decrease the $7.2 million is called the from $8.5 million for the same period last year, the cash cost, which again, it's the egg appreciation. This little of shape I, just can't take waste to 6.6 million from $6.7 million non cash cost of decrease just 0.6.

Andrew O'brien: with four features of options and unlisted RSUs related.

Andrew O'brien: those employees that were affected by the reduction in the workforce

Andrew O'brien: Production and Workforce, and this was offset slightly by an increase in depreciation of $900,000.

And for the 3 months from 1 point to the same period last year again, the symbol of decrease and on cash cost attributed the shape I just called the expense.

Andrew O'brien: General and administrative expenses decreased to $7.2 million this quarter from $8.5 million for the same period last year. The cash costs, which again exclude depreciation as well as share-based comp, decreased to $6.6 million from $6.7 million. Non-cash costs decreased to $0.6 million for the three months from $1.8 million for the same period last year. Again, a similar decrease in non-cash costs attributed to share-based comp. Other income and expense decreased by $2.3 million for the three months ending 30th June 2021 from other income of $0.5 million for the same period.

Other income and expense decreased about $2.3 million for the 3 months and so you said June 2021 from other income of zero point $5 million for the same period and.

Uhm the last year to another expense of $1.8 million. The day case was primarily due to the weakening of of the dollar relative to the pound during the same on sending cities of J and to pay to the the sea of can pay per day yesterday months for the pot pie.

Yeah.

Income tax benefit decrease the $6.4 million for the for the 3 months.

Andrew O'brien: Last year, to another expense of $1.8 million; the decrease was primarily due to the weakening of the dollar relative to the pound during the three months ending 30th of June compared to this year compared to the three months for the prior period.

And a third of June 2021 from $7 million from the 3 months and date. Please of June 2022, 2 of decrease in and R&D Uhm qualifying expenses and.

As research and development credit spelled out of foster right. The now that lost before income checks. The sled has led to of lower effective the text right research and development of credits or obtained at the maximum rate of 43.35 per cent of alcohol of fine research and development explained the checks and the increase in the net credit is primarily attributable.

Andrew O'brien: Income tax benefit decreased to $6.4 million for the three months ending 30 June 2021 from $7 million for the three months ending 30 June 2020 due to a decrease in R&D qualifying expenses, as research and development credits fell at a fast...

And increase this eligible expenses.

Finally, net loss of attributable to ordinary share holders was 33.2 million for the 3 months and and <unk> J 2021, and that's in case decided to put 1 million lost to the same period last year.

Andrew O'brien: effective tax rate. Research and development credits are obtained at a maximum rate of 33.35%.

Andrew O'brien: And the increase in the net credit was primarily attributable to an increase in this eligible expenditure.

The basic and <unk> and diluted net loss push towards my share of for the 3 months any studies of June 20th 21, titled 47 cents on that compares to the basic and diluted <unk> <unk> <unk> <unk> my share of 62 cents. So the cost of wandering period of last year.

Andrew O'brien: Finally, the net loss attributable to ordinary shareholders was $33.2 million for the three months ending 30 June 2021, and that compares to $32.1 million in losses for the same period last year. The basic and diluted net loss per ordinary share for the three months ending 30 June 2021 totaled $0.47, and that compares to a basic and diluted net loss per ordinary share of $0.62 for the corresponding period last year.

And just today to guidance on the on cash runway you know and we do have some concern about the continuing strength.

Of the pound relative to the dollar at current levels. It probably does take a little off the runway and we had the estimated post of the race that we we can and February but we still sort of confident and guarding at this point. The current on cash on hand will provide us with a cash runway into the first half of 2023 and.

Andrew O'brien: Just turning to guidance on cash runway, we do have some concern about the continuing strength of the pound relative to the dollar. At current levels, it probably does take a little off the runway. We had estimated post the raise that we did in February, but we are still sort of confident in guiding at this point that current cash on hand will provide us with a cash runway into the first half of 2023. And with that, I'll now hand the call back to Christian to give you a brief outlook on expected milestones. Christian

And with that Oh, now and the call back the Christian and give you a brief at look unexpected Boston and is Christian.

Alright, well. Thank you very much Andrew we're going to slide 21, Uhm believe we're gonna be headed into and exciting second half of this year with quite a significant amount of activities, particularly towards the end of the year. When we look at <unk> and the other 122, we expect obviously.

The first of all primary operational focuses on the execution of the pivotal study I think it's worth the worthwhile to it and I mentioned that the fee. Like study is wanted of very few pivotal studies 8 and it all day and they all of the day with a new agent of any kind of.

Christian Martin Itin: All right. Well, thank you very much, Andrew. We're going to slide 21. I believe we're going to be headed into an exciting second half of this year with quite a significant amount of activities, particularly towards the end of the year. When we look at OVCEL and Auto One 22, we expect, obviously, first of all, the primary operational focus to be on the execution of the pivotal study. I think it's worthwhile to mention that the FELIX study is one of the very few pivotal studies in adult ALL with a new agent of any kind, first off.

First off and secondly, it's 1 of the very few pivotal studies that are ongoing with a new product in the south at the end of car T space in particular.

And we are of reiterating our guidance to have the data during the course of next year and.

Uhm and and when we didn't look into the older 122, pediatric ALLL activity, we expect to give and update at the end of this year and.

Christian Martin Itin: Secondly, it's one of the very few pivotal studies that are ongoing with a new product in the cell therapy space, and the CAR-T space, in particular. We are reiterating our guidance to have data during the course of next year. And when we then look into the Auto I-22 pediatric ALL activity, we expect to give an update at the end of this year, as well as an update on the additional non-Hodgkin's indications from the old car study as well.

And as well and update on the additional non Hodgkin's indications from the old car study as well at the end of this year and.

The the primary CNS and foam activities, we expect will probably be of date of release early next year, and and and I think that gives us the and actually between those various indications talked to give us the very good view on the overall profile of the product across not only a and L. But the range of C. D 19.

Holidays Hematological malignancies.

Christian Martin Itin: The primary CNS lymphoma activities we expect will probably be a data release early next year, and I think that will give us, then, actually, between those various indications start to give us a very good view of the overall profile of the product across not only ALL but the range of CD19-positive hematological malignancies. Auto IV, we obviously are continuing to escalate that program. We expect interim data during the first half of next year, presented at one of the upcoming conferences during that period.

And the order for we obviously of continuing to those escalate that program. We expect entering data during the first half of next year per cent of on the the upcoming conferences in that period.

And Autistics and G is scheduled to end of the clinic Uhm and the first half of next year and we're running this program and collaboration with academic partners and we'll see and good progress and we're excited to Oh say get this pay should get this product back into patients and see the impact all of the improvements <unk>.

The end of off the all the 6 program the.

And the cash balance is Andrew pointed out the is approximately 260 million at the end of June the way the cash or on the way into the first half of 2023.

Christian Martin Itin: AutoSix NG is scheduled to enter the clinic in the first half of next year. We're running this program in collaboration with our academic partners, and we're seeing good progress, and we're excited to obviously get this product back into patients and see the impact of the improvements over and above the AutoSix program. The cash balance, as Andrew pointed out, is approximately $260 million at the end of June with a cash runway into the first half of 2023.

With that I think we're of through with the form of presentation and we're happy to take questions.

Thank you Sir as a reminder to ask a question you and nature Press Star 1 on your telephone.

Which are your question. Please press of the <unk>. Please.

Please stand by while we compiled the Q&A roster.

I show. Our first question comes from the line of Matt Fifth from William Blake. Please go ahead.

Operator: With that, I think we're through with the formal presentation, and we're happy to take questions. Thank you, sir. As a reminder, to ask a question, you would need to press star 1 on your telephone. To withdraw your question, please press the pound key.

1 of the guys fix or of let me the afternoons I stay of my questions. I guess first on auto 4 and 5 could you just talk about what pushed it back to the first half of next year and it's obviously been a a program of of interest for for investors and yet.

Operator: Please press the pound key. Please stand by while we compile the Q&A route.

Operator: I show our first question. It comes from the line of Matt Phipps from William Blair.

Been a while since we've hoping to see data.

Absolutely well first of all thanks for joining that what we did see with all of the 4 of 5 is still obviously as we were going through the first half of the year impact on the on the centers, we're not of through that which is very good and.

Matthew Christopher Phipps: Please go ahead. Good morning, guys. Thanks for joining me in the afternoon. Thanks for taking my questions. I guess, first on Auto 4 and 5, could you just talk about what pushed it back to the first half of next year? It's obviously been a program of interest for investors and yet, you know, it's been a while since we've been hoping to see data.

And we expect to be sort of the of the holding up the predicted right, but that was certainly something that we're still you would have to work from and was still sort of going to get and into the second quarter and a bit longer than thank frankly, hoping it would.

Christian Martin Itin: Absolutely. Well, first off, thanks for joining us.

Christian Martin Itin: What we did see with Auto 4.5 is still, obviously, as we go through the first half of the year, impact on the centers. We're now through that, which is very good. And we expect to be sort of enrolling at the predicted rate. But that was certainly something that we're still, you know, have to work through. And we're still sort of going to get into the second quarter, and a bit longer than I think, frankly. We're hoping.

Okay. Thanks, and then on on the field of study I guess some of it sounds like of and in fact of debated.

Do you think it's later this year that you can provide you can narrow that 22 guidance and maybe the first half of it you're a second half.

Well, let me let me be specific the guidance hasn't changed okay. So we're expecting the primary and point to be available middle of next year, and the time dependent and points being available at the end of next year. So that's the guidance and we've been given consistently and that is unchanged.

Christian Martin Itin: Thanks. And then on the FELIX study, I guess it sounds like COVID's impact has abated. Do you think it's later this year that you can provide, you can narrow that 22 guidance, maybe the first half, mid-year, second half?

Okay, So and I read and Hilarity and act on the feet like study.

And lastly, Bristol's and.

Christian Martin Itin: Well, let me be specific. The guidance hasn't changed, okay? So we're expecting the primary endpoint to be available in the middle of next year, and the time-dependent endpoint being available at the end of next year. So that's the guidance that we've been given consistently, and that is unchanged. Okay, so there is no impact on the feedback speed.

It seems to have a strong out of the gate quarter of 3 Ozzy and there's definitely some physician talk of of the safety of profile of being differentiated and and kind of driving more utilization does that give you more confidence and and broadening the scope of auto on development, even and some of these competitive indications.

Well first of all sorts of consistent whereas I think what we've been talking about on average side as well and almost the consistent with an investigative feedback that we've been been hearing.

Christian Martin Itin: Lastly, Bristol at least seems to have a strong out-of-the-gate corner with Beyonce, and there's definitely some position talk about the safety profile being differentiated and kind of driving more utilization. Does that give you more confidence in broadening the scope of Auto One development even in some of these competitive indications?

And what we're very encouraged the by is the fact that all of the city non Hodgkin's early on Hodgkins data give us also very clear indication that there'll be cell has a very attractive safety profile and the Hopkins as well I think that bodes very well. So as we had indicated wanted to get an overview on the other indications and get a good feel for the.

Christian Martin Itin: Well, first of all, obviously, it's consistent with, I think, what we've been talking about on our side as well, and obviously, consistent with the investigative feedback that we've been hearing. What we're very encouraged by is the fact that, obviously, the early non-Hodgkin's data also give us a very clear indication that OBCell has a very attractive safety profile in non-Hodgkin's as So, as we had indicated, we wanted to get an overview of the other indications to get a good feel for the competitive profile that we have in each one of those indications, and then we'll pick the one that looks strongest at that.

Competitive profile that we have and each 1 of those indications and the will that will pick the 1 that the it looks strongest at that point.

Alright, Thanks Christian.

Thanks and you.

Thank you I shall our next question comes from the line of Eric Joseph from J P. Morgan. Please go ahead.

Hi, Good morning. This is on hold on for the headache, and they will thanks for taking the questions.

First me with respect to the modem the collaboration of.

And you should I think on that on the phone and a mix of the date and the day of authentication of that maybe it's called within the goddess ended up moving on.

Operator: All right, thanks, Christian. Thank you. Thank you. Our next question comes from the line of Eric Joseph from J.P. Morgan. Please go ahead.

<unk>.

On the also like instead of payment associated with the selection of I'll get the indications they get the.

Operator: One more time, please go ahead.

And when should we expect more and you still on that line.

Operator: Hi, good morning. This is Rahul on behalf of Eric, and thanks for taking our questions.

And then my second question is the the nation, but the zoom authenticate them the the scarred of lightning and moving upstream and use how do you think about the competitive position.

Rahul: Firstly, with respect to the Moderna collaboration, can you share some color on the economics of the deal and the type of indications that may be explored within the broader field of the Green Accord? And also, like, is there a timeline associated with the selection of targets and indications? And when should we expect more news flow on that front? And then, my second question is in relation to the Zuma 7 data, with the ESCADA likely moving upstream in use, what do you think about the competitive positioning of Auto 3 or Auto 1 in the LBCL? And does this in any way impact your thinking about the future clinical development strategy for LBCL?

The <unk> the other 1 and the N B C and the best if in any way and back and thinking about the future authentic and develop those 1980 of them.

Alright, well thanks for the Doctor joining appreciate it so first questions to to the Mcgarrah and option of license agreement. So the the Binder said, we're looking at are are indeed, the broader and you know I'll call. The itchy field, we haven't actually narrow it back on in terms of the Arab <unk>.

Public statements, uhm, but obviously or artwork, but the the enabling enabling for approaches the the sort of fake within the technology that the murder of nice using on the M. R and a side and so it is I think important to understand this is technology that sort of is outside our basic and will be applied.

Christian Martin Itin: All right. Well, thanks a lot for joining me. I appreciate it.

Christian Martin Itin: So first, questions about the Moderna Optional License Agreement. So the binders that we're looking at are in the broader immuno-oncology field. We haven't actually narrowed that down in terms of our public statements, but obviously are enabling approaches that sort of fit within the technology that Moderna is using on the mRNA side. So it is, I think, important to understand this is technology that sort of is outside or basically will be applied outside of the core applications that we're using on the CAR-T side and, obviously, is sort of a very nice additional utility and revenue stream we can build up.

Outside of the core of applications that we're using on the car T side, and obviously are sort of and very nice additional utility and revenue stream and we can build up the the compensation itself is has obviously elements of the option exercise fees as well as.

The development milestones commercial milestones and royalties of classical structure, but we have the guy who the right the amounts related to that concentration, but it is the standard structure and the normal develop on progress and enjoy the rest of the program going forward.

Christian Martin Itin: The compensation itself obviously includes elements of option exercise fees as well as Development Milestones, Commercial Milestones, and Royalty, so a classical structure, but we haven't discussed the amounts related to that compensation, but it is a standard structure around the normal development progress and the geodesic and the program goals.

Second question related to Kennedy activities that we do see and the field moving car T therapy from the last 9 setting and D. O D. C. L into early of lines of setting and we've seen of the data from more than 1 program at the stage I think what he is very encouraging and also what we I think.

And I've been expecting and the field is debt as you move up the line you do actually start to see attractive attractive outcomes, including obviously and direct comparison to stem cell transplants did indeed, the activity looks more attractive on the car T side compared to the <unk>.

Christian Martin Itin: Second question related to the kind of activities that we do see in the field moving CAR T therapy from the last line setting in DOD CL into early lines of setting. We've also seen data from more than one program at this stage. I think what is very encouraging and also what we, I think, have been expecting in the field is that as you move up the line, you do actually start to see attractive outcomes, including, obviously, in direct comparison to stem cell transplants, that indeed the activity looks more attractive on the CAR T side compared to the stem cell transplant that I've seen.

And so a transplant on it it comes so I think that is a trend and I don't think we'll be seeing across the indications and and that will certainly be taken into account, that's the sort of thinking about our strategy and the non hodgkin settings on the on the past, we're gonna take with the with our respective programs.

That's very helpful. Thank you.

Thanks for joining.

Thank you I share. Our next question comes from the line of ethic of Monday and from Truist. Please go ahead.

Christian Martin Itin: So I think that is a trend that I think we'll be seeing across the indications, and that will certainly be taken into account as we're sort of thinking about our strategy in the non-Hodgkin settings and the path we're going to take with our respective indications.

Hi, guys the money and good afternoon. Thanks for taking my questions Uhm. So we have a tech hardest regulatory decisions and coming up Christian and I'm sure you guys have done on our doing some primary research on on to see how physicians do you the.

Rahul: That's very helpful. Thank you.

Operator: Our next question comes from the line of Asthika Goonewardene from Truist. Please go ahead. Hi guys, good morning, good afternoon.

Profile and how that compares to Obi so I'm only take the share some of the feedback with us I got a female follow ups after that.

Asthika Sarith Goonewardene: Thanks for taking my questions. So we have a TechCardis regulatory decision coming up. Christian, I'm sure you guys have done or are doing some primary research to see how positions view the profile and how that compares to OBCell. I wonder if you could share some of that feedback with us. I got a few more follow-ups after that. Right? So first of all, thanks, Asthika, for joining us and thanks for the question.

Right. So first of all thanks, and I'll stick up for joining and thanks for the question I think if you if you think back around and the communication of that we put out on the the analysts called every day of the Brian B E. H a meeting we did actually sort of look at compare and contrast, the data.

To the extent that double of sort of the appropriate to do I think what is what is clear is that we're obviously the the the profile of the product indicator of clearly and improvement for the patients with all the day of of of patients and I think that is a good thing.

Christian Martin Itin: I think if you think back on the communication that we put out and the analyst call that we did around the EHA meeting, we did actually sort of look at, compare, and contrast the data to the extent that that was sort of appropriate to do so. I think what is clear is that obviously the profile of the product indicates clearly an improvement for the patients, for adult ALL patients, and I think that is a good thing.

What we do see is and we're seeing consistently through the various presentations of and publications of data is at the head indicated and the slide before as well a significant level of toxicity that's associated with the treatment of the patients that certainly is is challenging to manage about 40 per.

The scent of the patients required debate and required ratio of pressure. So you can assume there's at least that proportion of of the patient is the most likely to actually have to be managed and and iced tea you and.

Christian Martin Itin: What we do see, and we've seen consistently through the various presentations and publications of data, is, as I had indicated in the slide before as well, a significant level of toxicity that's associated with the treatment of the patients. That certainly is challenging to manage. About 40% of the patients require the required laser presser, so you can assume that at least that proportion of the patients was likely to actually have to be managed in an ICU.

So it's it's and it turns patient management, that's required and there is clearly some time and <unk>. When we when you look at the overall data. It does not look like there was a stabilization of the the responses overtime. If you look at the eventually survival of treacher, but there.

Clearly of getting in time, so overall I think progress for the patients, but I think when I think from our products perspective from the date of that we have today from the program. We believe we have and attracting said the day to that I'm sure. The ladders to differentiate in this particular disease spreading.

Christian Martin Itin: So it's intense patient management that's required, and there is clearly some time gained. However, when you look at the overall data, it does not look like there is a stabilization of the responses over time. If you look at event-free survival, etc., but there is clearly a gain in time. So overall, I think progress for the patients, but when I think from our product's perspective and the data that we have to date from the program, we believe we have an attractive set of data that should allow us to differentiate in this particular disease setting.

The transfer.

I'm wondering could you and also give us maybe some guidance on the number of patients, we can expect or the auto or update and the first half of 22.

So what we're we're rolling in the the the nature of the study with all of the 4 is is the classical dose escalation study. So we expect that we're going to have probably in the range of approximately 10 patients at the time of of presentation somebody that poor and that order.

Christian Martin Itin: Thanks Christian.

Asthika Sarith Goonewardene: I was wondering, could you give us some guidance on the number of patients we can expect for the Auto IV update in the first half of 2022?

Got it and then lastly, yep.

We're looking forward to seeing the auto 7 and studied dot and price off of 22 as well, but we can send the unfortunate events another piece of nature.

Christian Martin Itin: So what we're rolling in, the nature of the study with Auto-4 is a classical dose escalation study. So we expect that we're going to have probably in the range of approximately 10 patients at the time of presentation, somewhere in that order. And then lastly, we're looking forward to seeing the Auto7 study start in First Alpha 22 as well, but we've seen some unfortunate events for another PSMA-directed CAR-T in similar

T and and and and from the setting I'm not sure if Martin and so on the line or you can channel and get in the much and here, but maybe sometimes what gives you. Some what do you think of driving that incidents of macrophage activation syndrome, and does that and talk to the cities with the competing kiss and a car T and would you need to manage for that and.

And with all the 7 on <unk> are you confident that that might be something that you know all kind of share.

Asthika Sarith Goonewardene: I'm not sure if Martin's on the line or if you can channel your inner Martin here, but maybe we can...

So the first off I would say, there's very little no and about what actually have.

Christian Martin Itin: What do you think is driving that incidence of Macrophage Activation Syndrome, and does that have to do with toxicity?

Happened and in that data set and I think we need to wait for the actual publication or presentation of of the medical conference to understand kind of of what the actual day days I think at this point, it's pretty much reference to the to the press release to my knowledge.

Christian Martin Itin: and those other toxicities with the competing PSMA quality, and would you need to manage for that with order 7 or are you confident that that might be something that you're not going to share? So first off, obviously, there's very little known about what actually happened in that data set, and I think we need to wait for the actual publication or presentation at a medical conference to understand kind of what the actual data is.

Uhm. So so that's difficult to judge at this point in time I think what we what we can Josh Uhm for the first of all of what we can do from from the restaurants shallow and design wanted to keep and use of elements that we have in a row and design is actually the use of I'll switch instead of the ability to stop the activity of the car if he should that be necessary. So that's 1 of the <unk>.

Christian Martin Itin: I think at this point, it's pretty much a reference to a press release, to my knowledge. So that's difficult to judge at this point in time. I think we can judge, first of all, what we can do from a reference to our own design. One of the key things or elements that we have in our own design is the use of off switches, an ability to stop the activity of the CAR T should that be necessary.

<unk> that's been named the program from the gecko.

What is interesting I think is too it's probably 2 additional data points and the so the delight of P. S and a field first day is the program from the <unk> with the Radiolabeled P. S from a antibody I have which obviously has hit the primary and points interface free trial and the has had a good.

Christian Martin Itin: So that's one of the measures that's been in the program from the get-go. Now, what is interesting, I think, are probably two additional data points in the wider PSMA field. The first is the program from Novartis with the radio-labeled PSMA antibody, which obviously has hit the primary endpoint in a phase three trial and has had a good overall safety profile, as was sort of communicated earlier in the year. So clearly, an ability to target PSMA with a very potent mechanism of action.

A good old rule of safety profile, Uhm, asthma, and I sort of communicated earlier and the ear, so clearly and the ability to target P. S. M. A with a very potent mechanism of action and addition, Amgen is moving forward and what was prior the N G 160 program, which.

The P S and they bite so again redirecting T cells 2 P S and the expressing sales. The program. Obviously has had some of the pay the some of the day that presented and is now clearly moving forward also and combination and with a range off and probably the products that are used in the home.

Christian Martin Itin: In addition, Amgen is moving forward with what was previously the NG-160 program, which is a PSMA byte, so again, redirecting T cells to PSMA expressing cells. That program obviously has had some data presented and is now clearly moving forward also in combination with a range of products that are used in the hormone-refractory prostate cancer space. So there are at least two programs, one, a T cell program, and the other one, a very high activity program against PSMA, which do not seem to have the type of adverse events that sort of have been anecdotally described.

And refractory prostate cancer space. So so the at least 2 programs with the <unk> program and the other 1 of very high activity program against P. S and a which I do not seem to have the type of adverse events and that sort of has been been anecdotal the described.

So from that perspective, I don't think we have kind of the the knowledge at this point, whether this is a a target issue with this amount of the issue I think we have to wait for the release of the data.

Great. Thanks for taking my question on guys.

Thank you.

Thank you I'm ex question comes from the the line of chat Messer from Needham and company and please go ahead.

Asthika Sarith Goonewardene: So from that perspective, I don't think we have any kind of knowledge at this point whether this is a target issue or whether it's a model issue, and I think we have to wait for the release of this. Great. Thanks a lot.

[noise] great. Thanks for taking our questions a couple of from us, but let me start out with the and acknowledgment.

Galatians of the of the Moderna deal Uhm, obviously, not the key focus and valued driver right now, but I think of nice.

Operator: Great. Thanks for taking my question, guys.

Validation of the the differentiated work you're doing on on cartoon enabling technologies.

Chad Messer: Thank you. Our next question comes from the line of Chad Messer from Needham & Company. Please go ahead. Great, thanks for taking our questions, a couple from us, but let me start out with an acknowledgment and congratulations on the Moderna deal, obviously not the key focus and value driver right now, but I think a nice validation of the differentiated work you're doing on CAR T-enabling technology. So maybe just start with the AASH from the all-car extensions in the high grade. NHL, and CLL, maybe set the stage on what we should look for there and how those indications are different. different from what we've seen before.

So maybe just start with the 8 ash from the all car extensions and and and the high grade.

And H L. C O L. Maybe set the stage on on what you what you should look for their and and how was those indications of different.

The different from from what we've seen before.

Thanks, a lot for joining Jack so the indications that we're always the exploring and the old car extension are uhm, obviously of what we already updated on our patients that have follicular lymphoma <unk>. So the the primary disease.

Patients that do have mantle cell lymphoma, and then on the hi, Great site and you would be looking at the L. D. C. L. And then in addition to those 3 we're also looking at patients with C O L.

Christian Martin Itin: Thanks a lot for joining us, Jack. So the indications that we're obviously exploring in the All-CAR Extension are obviously what we have been updated on are patients that have follicular lymphoma as sort of the primary disease, patients that do have mantle cell lymphoma, and then on the high-grade side, you would be looking at DLD-CL. And then, in addition to those three, we're also looking at patients with CLL. So all of those are small exploratory cohorts, and we expect to report on all of those.

So these are all all of those of small exploratory cohorts and we expect the report on all of those but it also labolt or not and I think we'll see as we got closer to the end of the year, but I think we will get a very good sense overall of for the activity of the product the cross the range of the indications.

Alright, Great and day Alright, I was also curious you could.

Maybe briefly talk a little bit more about the reset nature of publication, which talks about stem so memory T cells as perhaps being.

Christian Martin Itin: Whether they're all fully enrolled or not, I think we'll see as we get closer to the end of the year. But I think we will get a very good sense overall for the activity of the product across the range of indications.

The part.

Part of the mechanism for for for for durability, I'm, not really familiar with the east stem cell memory memory T. Sales of this is this something there's a particular marker for it so.

Chad Messer: I was also curious if you could maybe briefly talk a little bit more about the recent Nature publication which talks about stem cell memory T-cells as perhaps being, um, part of a mechanism for durability. Not really familiar with these stem cell memory T-cells. Is this something there's a particular marker for? Is this a well-known or relatively new phenomenon? Maybe just a couple words on that.

Ah well known or or relative me new phenomenon, maybe just a couple a couple of words on that.

Right. So so 1 of the remarkable things that were receiving and the original Oh the longer Ivy Shellwork that'll style and the other pediatric patients was that we had observed this exceptional persistence and the children and we did see you know of persistent the 3 years and longer and in fact has and the ability to act.

<unk> take blood samples from the kids and actually analyze the competition of car T spy flow and we could do that because of the levels of khaki sales in circulation were high and.

Christian Martin Itin: Right. So one of the remarkable things that we were seeing in the original auto one or ob-cell work that was done on the pediatric patients was that we had observed this exceptional persistence in the children. And we did see persistence of three years and longer, and in fact, we had the ability to actually take blood samples from the kids and actually analyze the composition of CAR T cells by flow. And we could do that because the levels of CAR T cells in circulation were high.

And that actually lives at Allied us to have actually sufficient material to really do a proper analysis of what's the the compensation of yourself that we're seeing and what what is it that receive that the that's driving it. We could also then actually look at patients and at the products that could actually and and and children that actually did have responses and children and that he did.

And I'll halfway sponsors and.

Christian Martin Itin: And that actually allowed us to have actually sufficient material to really do a proper analysis of what's the composition of the cells that we're seeing and what is it that we're seeing that's driving it. We could also then actually look at patients and at the products that could actually work in children that actually did have responses and children who did not have responses. And the subset of T cells, the differentiation state you mentioned just before, with the stem cell-like character or characteristic, seemed to be present in those kids that actually did have a proper expansion and a response to the disease, but it seemed to be absent in the kids that did not respond.

And the the subset of of <unk>. The differentiation steak you mentioned just before with the standard like character of characteristic seemed to be president and those kate's that actually did have the appropriate expansion and the response to.

The the disease, but it seems the seem to be accident in the case actually that did not respond. So it is something that I think it's a it's a it's an interesting observation will obviously would like to corroborate that and the large of data set.

But I think it is interesting because it may point to surf and differentiation stay off the sales that seems to be associated with outcome and I think that needs to be obviously further investigated and show the cooperated and how about I think it may get the start to give us a sense of some of the the drivers that may actually give us the Ah.

Christian Martin Itin: So it is something that I think is an interesting observation. We obviously would like to corroborate that in a larger data set. But I think it is interesting because it may point to a certain differentiation state of the cells that seems to be associated with outcome. And I think that obviously needs to be further investigated and further corroborated. But I think it may start to give us a sense of some of the drivers that may actually give us a good indication about the ultimate quality of the product. So I think that's kind of what the paper was about and was basically putting forward as an observation, a hypothesis that obviously needs to be corroborated going forward in larger data sets.

Good indication about the ultimate quality of of the product and.

So I think that's kind of of what we were what the the the the paper was what was about it and was basically putting forward on to out of that as the observation hypothesis that all of the state you know needs to be corroborated going forward and lodge of day to sense.

Okay, Great day, great help on and maybe just a quick 1 for for Andrew Uhm and your.

And.

And your comments on the P&L you attributed the 1 and a half million dollar line eat of something I I didn't I didn't catch that.

I suggested that the the licensing come into the quota included the upfront and up from payments from madrone.

Chad Messer: Great. Thanks. Thanks. Helpful. And maybe just a quick one for Andrew in your, in your comments on P&L, you attributed the $1.5 million fee to something. I didn't catch that.

Okay and it made it into 2 cute alright. Thank you.

Yeah, It did make it into Chutki yep.

And.

Thank you.

I saw the last question comes from the line of Kelly She from Jeffries. Please go ahead.

Andrew O'brien: I suggested that the licensed income for the quarter included the upfront and upfront payments from...

Alright. Thank you for taking my question I have a question auto that's probably close this on the automated and manufacturing price tag.

Andrew O'brien: And that's all the statements from Moderna.

I remember all car 19 Coke on me at that and Wow improve giving sounds great of happening and just got impatient and trade. It in ways accounts <unk> optimizing my ex 9 of how can the ketchup.

Andrew O'brien: Okay, that made it into 2Q. All right, thank you. Yeah, it did make an intro.

Chad Messer: Yeah, it did make it into 2Q.

Operator: I show our last question, which comes from the line of Kelly.

Operator: And on the line is Kelly Shee from Jefferies. Please go ahead.

I Wonder if the day additional balance to also transfer and it took that her and that is you can enter of faint survival anytime you of amount I.

Kelly Shee: Thank you for taking my questions. I have a question on Autolus fully closed, the semi-automated manufacturing process. I remember that for all CAR-19 programming, adult ALL improved the response rate that has been observed in the patients treated with the cell products from this optimized manufacturing process. I wonder if this additional benefit also translated to better event-free survival at 24 months. I don't know if you have done stratified analysis on that. And also, for the extension trial and other upcoming trials, are you also using this manufacturing process to have better efficacy? And lastly, is there any impact on the cost of goods sold from this fully closed manufacturing process? Thank you.

I don't know if you have doubts satisfied on now and I think on that and also alpha the expansion on trial and the other.

Upcoming trial, I honestly, using the manufacturing price that better advocacy.

And the last for me and there any impact on cost us a good salad of found me fully close the manufacturing place okay.

Very good well thanks, a lot of Kelly very good questions. So uhm as you pointed out when the expiration of <unk> in the adult patients started the first few patients were treated with productive was generated and frankly by hand, Tuesday, and classical style of culture.

Similar to actually the way can Brian was manufactured.

Christian Martin Itin: Very good. Well, thanks a lot, Kelly.

The majority of the patients have ever of within 90 factor of using the of closed system that we're also using obviously from a commercial perspective and all the city is the basis for the pivotal study as well as the basis factor for all of the other programs that we have on in the past, but also running <unk> I was on and at this point in time.

Christian Martin Itin: Very good questions. So, as you pointed out, when the exploration of OBCell in adult patients started, the first few patients were treated with a product that was generated, frankly, by hand using classical cell culture, similar to the way Kymriah was actually manufactured. The majority of the patients, however, were then manufactured using the enclosed system that we're also using, obviously, from a commercial perspective, and obviously, it's the basis for the pivotal study, as well as the basis, frankly, for all the other programs that we have run in the past but also are running at this point in time.

So when we when we look at the at the potential impacts of what what are you referring to instead of the it looks when you looked at these initial patients and the old car study that the patients that were actually manufactured with the with the commercial manufacturing process, they look attached better than the pain.

<unk> and that were initially manufactured by hand and that is true. It does look different. The question is whether this is a true difference in the in and related to manufacturing or whether it was an overhang on patients that just didn't have a place to go and go and which is basically kept or managed to just about getting into the trial the.

Christian Martin Itin: So, when we look at the potential impact, what you were referring to is that, obviously, when you looked at these initial patients in the all-car study, that the patients that were actually manufactured with the commercial manufacturing process looked a tad better than the patients that were initially manufactured by hand. That is true. It does look different. The question is whether this is a true difference related to manufacturing or whether it was an overhang of patients that just didn't have a place to go and were just basically kept or managed to just about get into the trial. That is difficult to discern.

It is difficult to day, Sir and I'm looking at the individual contributions and the F. S. Actually gets very tricky because we just don't have enough patients that were actually manufactured by hand and.

And so that analysis becomes very difficult to do because the liberal you <unk> you don't have enough patience to fall, though uhm by I you would you would assume that they probably date of Tad worse and.

Christian Martin Itin: Looking at the individual contributions on EFS actually gets very tricky because we just don't have enough patients that were actually manufactured by hand. So, that analysis becomes very difficult to do because, literally, you don't have enough patients to follow. By eye, you would assume that they probably did a tad worse because, also, obviously, some of these patients did not receive any. So there is potential impact, but whether it's causal or not, I think that's not an easy one to really firmly conclude.

Because also obviously some of these patients did not respond. So so there is potentially impact by the way the it's cause of or not and I think that's not an easy 1 to the to to reconfirm that conclude what I think we can say is that the manufacturing process using the and closed system actually is and obviously more robust uhm and.

Try the likely more reproducible and and I think that contributes over on up to the quality of the outcome to the quality of the trial and it is the fact that it is send the automated which actually has an impact on the overall the cost of goods because it actually reduces the operator time that you need to put a and per product manufactured.

Christian Martin Itin: What I think we can say is that the manufacturing process using the enclosed system is obviously more robust, and it's highly likely to be more reproducible. And I think that contributes overall to the quality of the outcome, the quality of the trial. And it is the fact that it is semi-automated, which actually has an impact on the overall cost of goods because it actually reduces the operator time that you need to put in per product manufactured. And the fact that you can produce more products.

And factor you can produce more and more product, you'll also actually kind of simplify the manufacturing infrastructure because with the and close process on the send you out of the night. It set up you can actually run and a large number of product and parallel and the very same sweet without physical separation.

Since the singles and where he can of on demand that obviously it gives you a more efficient environment to work and compares to and approach where you actually do manual and open 90 palatial all of the patient samples and and that requires you to actually get on and operate and who.

Christian Martin Itin: You can also actually simplify the manufacturing infrastructure because, with the enclosed process on the semi-automated setup, you can actually run a large number of products in parallel in the very same suite without physical separation. So it is a single room where you can run them. That obviously gives you a more efficient environment to work in, compared to an approach where you actually do manual and open manipulations of the patient samples.

Within a clean room, and each product segregate it physically as and and if I into and individual room, 1 product per room to sort of actually on that manufacturing. So there is quite an impact on the Oprah will cost of that is associate it but it's also on the consistency of manufacture because you reduce the actual off.

Christian Martin Itin: That requires you to actually operate in hoods, within a clean room, and each product segregated physically into an individual room, one product per room, to actually run that manufacturing. So there is quite an impact on the overall cost that is associated, but it is also on the consistency of manufacture because you reduce the actual operator manipulations per product, and that actually is giving you an advantage in terms of efficiency and the cost of manufacturing.

Right of any information per product and that actually is giving you and the town pitch in terms of the efficiency and the the cost of manufacture.

Kelly Shee: Thank you very much.

Well, thank you very magical from.

Thanks, a lot of Kelly.

Thank you that can I come from.

Q and a session at this time and I'd like to turn the call back over to Mr. Christian and Eitan E O for clothes and comment.

Well. Thank you very much for joining thanks for all the questions. We're looking forward to obviously of keeping update it hope you get a bit of of stomach break and then we'll get back together at the latest obviously when we're getting into the September swing and the back on the on the normal circuit alright, well. Thank you very much have a great day and I will speak to.

Christian Martin Itin: Thank you very much, Christian.

Operator: Thank you. That concludes our Q&A session. At this time, I'd like to turn the call back over to Mr. Christian Itin.

Christian Martin Itin: Christian Itin, CEO, for closing comments.

<unk>.

Thank you. This concludes today's conference call. Thank you for participate and you may now disconnect good day.

Christian Martin Itin: Well, thank you very much for joining us. Thanks for all the questions. We're looking forward to keeping you updated. Hope you have a bit of a summer break and then we'll get back together at the latest, obviously when we're getting into the September swing and back on the normal circuit.

[music].

Operator: All right. Well, thank you very much. Have a great day, and I will speak soon. Thank you. This concludes today's conference call. Thank you for participating.

Operator: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect. Good day. Thank you for watching!

Operator: © BF-WATCH TV 2021 [inaudible] We are a non-profit organization. We are not responsible for the content of this film. We are not responsible for the content of this film. We are not responsible for the content of this film. [inaudible] ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ??

[music].

[music].

[music].