Q2 2022 Autolus Therapeutics PLC Earnings Call

August 4, 2022

Operator: Hello ladies and gentlemen, welcome to the Autolus Therapeutics second quarter 2022 financial results conference call.

The con.

[music].

Hello, ladies and gentlemen, and welcome to the <unk> Therapeutics second quarter 2022 financial results.

As a reminder, this conference call is being recorded.

Thank you for taking our questions and congrats on the progress.

And a last one for Lucy.

As a reminder, this conference call is being recorded.

Towards the end of the call. We will have a Q&A portion if you would like to be put in the Q. A first come first serve press star one one and at that time.

Will be called upon to ask your question without further Ado I would like now to turn the conference over to your host Olivia Mansour Director Investor Relations Olivia. Thanks.

Towards the end of the call, we will have a Q&A portion.

Thanks, Gil.

Can you provide any information on the potential cadence of Blackstone milestones, particularly given that you're going to have a pivotal readout in the fourth quarter and a filing in 2023?

Thanks, Corey good morning.

Everyone and thank you for joining us and stay cool.

<unk> financial results and operational highlights for the second quarter of <unk>.

And if that's all right.

And with me on the call.

<unk>, our chief Executive Officer and Don.

Lucinda Crabtree, our Chief Financial Officer.

So on slide two before we begin I would just like to remind you that during today's call. Our discussion will contain forward looking statements. Please make sure you are familiar with this slide.

On slide three you should see the agenda for today, which is upcoming Christian life of.

Of our operational highlights for the second quarter.

See NUCYNTA will then discuss the company's financial results. The full Kristian will can play with the upcoming milestones and any other key trading comments and will then turn over to Q&A.

I'll now hand over to Christian to begin the presentation.

Yeah.

If you would like to be put in the queue, first come first serve, press star 11.

Thank you, Gil.

Yeah, thanks, Gil.

Thank you Olivia and good morning to you all and thank you for joining US. It's my pleasure to review our progress for the second quarter in 2022, please move to slide number four.

And at that time, you will be called upon to ask your question.

Operator: Next up is Kelly Shi from Jeffries.

And I mean, as you know, we haven't specifically broken out those, milestone payments.

For those who are new to Atlas and as a refresher for those of you who know US well we are building a fully integrated car T companies building in our plant broad platform of cell programming technology for generated car T products that are tailored to the specific tumor setting we are addressing.

Olivia Manser: Without further ado, I would like now to turn the conference over to your host, Olivia Manser, Director, Investor Relations.

Operator: Olivia, thanks.

Olivia Manser: Thanks, Corey.

But, you know, what we have said is that these are related to development and regulatory milestones.

We had a successful quarter with multiple readouts from our clinical programs at the European Hematology Association Congress in Vienna in June , which gives us a great confidence in the inherent value of our pipeline and the progress achieved.

Good morning, everyone.

And thank you for joining us to take part in today's call on the financial results and operational highlights for the second quarter of 2022.

Kelly Shi: The question is for Pediatric ALL, could you share any color on the enrollment pace and, is the focus only on chimeria in eligible patients and any timeline you're targeting for the next phase of the study?

We continue to enroll patients into the pivotal Felix trial, where we're investigating ob cells for the treatment of relapsed refractory adult acute lymphoblastic leukemia patients and in April we obtained a regenerative medicine advanced therapy or <unk> designation from the FDA.

I'm Olivia Manser, Director of Investor Relations and with me on the call are Dr. Christian Eichin, our Chief Executive Officer, and Dr. Lucinda Crabtree, our Chief Financial Officer.

Kelly Shi: And also, I'm curious, which programs beyond ALTER1 will be prioritized for internal pipeline, development given the focus on commercialization in adult ALL probably should be expected for the next two years?

As a consequence, we now have preferred regulatory access for Ob sell in all key territories. The U S Europe and the U K and have met with the FDA in the context of a type b meeting to discuss the regulatory pathway going forward.

Thank you.

We're on track to announce the initial results for the Felix trial in Q4, 2022, which will be provided by way of a press release and were planning our presenting the full data set at a medical conference in mid 2023, most likely at <unk>.

Christian Itin: Yeah, thanks, Kelly.

As previously announced in addition to the primary morphological cohorts in the Felix trial, we have expanded the MRC cohort to enroll up to 50 patients.

Really good question.

So, with regards to the patient population we've been targeting in Pediatric ALL, obviously, for the initial patients we were going for, kids that have basically no option left to have access to proper therapy, and that is certainly the next phase of the study.

Clinical practice patients get evaluated on a regular basis for recurrence of disease, typically using slow analyses or PCR of their bone marrow samples.

And also, I'm curious, which programs beyond ALTER1 will be prioritized for internal pipeline, development given the focus on commercialization in adult ALL probably should be expected for the next two years?

Thank you.

Indication of minimal residual disease levels of leukemic ltvs triggers treatment of the patients rather than waiting for full blown morphological relapse too.

To occur.

This additional cohort does not impact our planned filing timelines as the primary data will be based on the data from the morphological cohort. However, we do believe the <unk> broadened the data set across a full range of tumor burden and align with current clinical practice.

Yeah, thanks, Kelly.

We remain fully focused on generating the data package needed to file for BLA approval for Ob cell for the treatment of adult patients with acute lymphoblastic leukemia and remain confident in <unk> potential to be a best in class treatment in a growing market.

Really good question.

As I mentioned EAA was a very busy meeting for us with data readouts for multiple clinical programs and I will go into more detail about the specific data later in this presentation.

But in summary, <unk> continues to show what we believe to be best in class activity with a high level of sustained complete remissions in NHL patients without inducing severe cytokine release syndrome or any neurotoxicity. In addition, we have now seen first activity in primary CNS lymphoma patients.

Beyond the Ob sale, we've seen first a promising results from the dual targeting Ottawa 22 program in children with acute lymphoblastic leukemia, who are ineligible for tumor therapy. The data presented at <unk>. We believe have demonstrated clinical proof of concept with a high level of activity and a valid manageable safety profile for <unk>.

And what we could demonstrate is obviously a very high level of activity, good safety.

Particularly excited about auto for reaching clinical proof of concept in patients with peripheral T cell lymphoma, reaching metabolic crs, while maintaining a bell manageable safety profile.

This data validates a novel targeting approach, which is very important given the high unmet need in this difficult to treat patient population.

With two new programs, reaching clinical proof of concept our pipeline beyond the Ob cell is advancing well and we're pleased with how it shaping up.

Finally, we're pleased in the quarter to dose our first patient in the phase one study <unk> eight for the treatment of patients with relapsed refractory multiple myeloma and all.

It's on track for autos fixed Mg our first solid tumor program to start a phase <unk> in the second half of the year.

The build of our commercial manufacturing facility in Stevenage is progressing on track with its schedule I'll cover that in more detail later in the presentation.

Lucinda will then discuss the company's financial results before Christian will conclude with the upcoming milestones and any other concluding comments, and we'll then turn over for Q&A.

And with that, I think we have sort of established kind of the basic profile of the product.

So, I mean, you know, read into that as you will, Gil.

Moving to slide five.

As we go forward, I think there's an opportunity to also enroll patients that would be eligible, and I think that becomes a possibility as we start to move forward.

Some of the key activities that we're engaged in in that program is also to do some modifications, of the manufacturing process as well and kind of actually we'll explore that in a group of additional patients.

Olivia Manser: I'll now hand over to Christian to begin the presentation.

And I think that data set will then actually sort of form the basis for any decision on, moving the program forward. So we expect that data to become available of this initial cohort during probably the, middle of next year and that also then actually gives us then the basis for moving the program forward.

Okay.

With that let's focus on our lead product Ob sale and move to slide six just to remind you <unk> has a unique mechanism of action and built on a highly specific engagement of CD 19, coupled with a fast release from CD 19 wants to kill the leukemic cell has been initiated.

In terms of prioritization, you're correct, we have obviously quite a set of interesting, opportunities we're building to.

Very helpful.

Thank you for taking our questions, and congrats on the progress.

This fast as engagement is based on the fast off rate of the cat Binder and drive three key properties of Ob sales reduction of the amount of cytokine release.

<unk> targets selling character, which in turn will reduce the amount of immune toxicity of the patients reduced exhaustion in the car T cell and improved and graph and overall persistence of the product.

Christian Itin: Thank you, Olivia, and good morning to you all, and thank you for joining us.

Thanks, Gil.

And those of you not familiar I refer you to a paper by historic Russia at nature Medicine in 2019.

It's my pleasure to review our progress for the second quarter in 2022.

Thank you, Gil.

Moving to slide seven.

It still remains a very high unmet medical need for adult AML patients with approximately 8400, new cases diagnosed yearly worldwide in the last slide setting approximately 3000 patients of these cases resided in the U S and Europe .

Please move to slide number four.

Next up is Kelly Shi from Jeffries.

For those who are new to Autolus, and as a refresher for those of you who know us well, we're building a fully integrated CAR-T company. Building on our broad platform of cell programming technologies, we're generating CAR-T products that are tailored to the specific tumor setting we're addressing.

The question is, for pediatric ALL, could you share any color on the enrollment pace, and is the focus only on King-Ryan ear-eligible patients?

We had a successful quarter with multiple readouts from our clinical programs at the European Hematology Association Congress in Vienna in June, which gives us great confidence in the inherent value of our pipeline and the progress achieved.

And in timeline, you're targeting for the next phase of the study.

And also, I'm curious, which programs beyond ALTER-1 will be prioritized for internal pipeline development, given the focus on commercialization in adult ALL probably should be expected for the next two years?

This combination chemotherapy enables 90% of adult <unk> patients to achieve Crs.

Thank you.

<unk> complete remissions, only 30% to 40% will achieve long term remission.

Yeah, thanks, Kelly.

Once relapsed patients have a median overall survival of less than a year.

Really good question.

Current approved therapy for adult patients in plain sight, though and the Carters and <unk> is currently approved in the U S. And has received a favorable <unk> opinion in Europe and is expected to be approved in Europe later in the year.

So, with regards to the patient population, we've been targeting in pediatric ALL, obviously, for the initial patients we were going for, kids that have basically no option left to have access to proper therapy, and that is certainly a concern.

These therapies are highly active but frequently followed by subsequent treatments typically including allo stem cell transplants.

<unk> has a favorable safety profile with few patients experiencing severe cytokine release syndrome, and ICANN, but with limitations on convenience due to the need for continuous IV infusion gerrick, it's four week treatment cycles.

Carter's is more challenging to manage and reduces elevated levels of severe crs.

High level of icons or neurotoxicity and require steroids and base of presses for many patients to manage adverse events.

Both therapies have been shown to be highly active however, most patients progressed rapidly and require subsequent allograph to achieve durability.

So, we're targeting for the next phase of the study, and also, I'm curious, which programs beyond ALTER-1 will be prioritized for internal pipeline development, given the focus on commercialization in adult ALL probably should be expected for the next two years?

Moving to slide eight.

Building on its unique mechanism of action <unk> has showed a high overall response rate with favorable with a favorable safety profile and sustained da Vinci survival that tracks long term persistence in those patients.

We continue to enroll patients into the Pivotal FELIX trial, where we're investigating OB cell for the treatment of relapsed refractory acute lymphoblastic leukemia patients, and in April, we obtained, a Regenerative Medicine Advanced Therapy, or RMAT, designation from the FDA. As a consequence, we now have preferred regulatory access for OB cell in all key territories, the U.S., Europe, and the U.K., and have met with the FDA in the context of a Type B meeting to discuss the regulatory pathway going forward.

The key focus is going to be on delivering OVCell and get OVCell to market.

Thank you.

That's clearly where the primary focus of the organization is.

Yeah, thanks, Kelly.

But there will be opportunities as we go through the course of next year to actually look at, advancing some of the earlier programs, including Auto-122 as well as Auto-4, which I think both of them will start reaching interesting data points during the course of next year and I think will become programs that can be fully developed.

Really good question.

As mentioned before or we sell has been granted orphan drug designation by the FDA and EMA for ALLL and obtained prime designation by EMA for the EU ILEC designation by the MH array for the U K and most recently, our Mac designation by the FDA for the U S.

So at that point in time, I think that's it.

So, with regards to the patient population we've been targeting in pediatric ALL, obviously, for the initial patients we were going for, kids that have basically no option left to have access to proper therapy, and that is certainly the case with children who sort of passed or beyond patients.

And what we could demonstrate is obviously a very high level of activity, good safety.

Thank you very much.

And with that, I think we have sort of established kind of the basic profile of the product.

Moving to slide nine.

Thanks, Kelly.

As we go forward, I think there's an opportunity to also enroll patients that will become eligible.

Based on what we believe is potentially a transformational data from the old car study we are treating patients. We're conducting the pivotal field study trial with approximately 90 patients in the so-called morphological cohort. We're treating currently patients at 34 sites across the U S. The UK and Spain.

Operator: All right, next up we have Chuan Hong from J.P. Morgan.

I think that becomes a possibility as we start to move forward.

Operator: Stand by.

We're on track to announce the initial results for the FELIX trial in Q4 2022, which will be provided by way of a press release, and we're planning on presenting the full data set at a medical conference in mid-2023, most likely at AIR.

Chuan Hong: In your- Hi, this is Chuan.

We're on track with our previous guidance and expect to announce initial results of the fourth quarter. This year, which will be in the shape of our press release, we're planning on presenting full data at a medical conference in the first half of 2023 as indicated.

Hi, this is Chuan Hong for Eric Joseph.

Thanks for taking our question.

Chuan Hong: So just a follow-up on the Auto4 program.

Currently think of that <unk>.

In order to maximize outcomes from the Felix trial in parallel we have initiated an additional cohort of up to 50 patients in the second related complete remission.

As previously announced, in addition to the primary morphological cohort in the FELIX, trial, we have expanded the MRT cohort to enroll up to 50 patients.

So since the updates are ehaa, are there any new interpretation of the lack of Auto4 expansion in the peripheral?

In clinical practice, patients get evaluated on a regular basis for recurrence of disease, typically using slow analysis or PCR of their bone marrow samples. Indication of minimal residual disease levels of leukemia triggers treatment of the patients, rather than waiting for full-blown morphological relapse to occur.

In second or later complete remission, we have minimal residual disease. So called MRC positive patients. However, this additional court does not impact our planned filing timelines as the primary data will be based on the data from the morphological cohorts.

This additional cohort does not impact our planned filing timelines, as the primary data, will be based on the data from the morphological cohort. However, we do believe the MRT cohort will broaden the data set across the full range, of tumor burden and align with current clinical practice.

We remain fully focused on generating the data package needed to file for BLA approval, for OBCell for the treatment of adult patients with acute lymphoblastic leukemia, and remain confident in OBCell's potential to be a best-in-class treatment in a growing market.

Chuan Hong: And do you expect the product made, from the modified manufacturing process to have an impact on the 4-cell phenotype and expansion potential?

Some of the key activities that we're engaged in in that program is also to do some modifications of the manufacturing process as well, and kind of actually we'll explore that in a group of additional patients.

Moving to slide 10.

And switching gears.

As we move into slide 11.

So yeah, that's it.

And I think that data set will then actually sort of form the basis for any decision on moving the program forward.

<unk> unique profile means it could be applicable to a broad range of indications, where consequently evaluating the product outside of acute lymphoblastic leukemia in b cell non Hodgkin's lymphomas illustrative ongoing phase one clinical studies as I mentioned, we have positive clinical readouts at the recent Congress from phase one.

As I mentioned, EHA was a very busy meeting for us, with data readouts from multiple clinical, programs, and I'll go into more detail about the specific data later in this presentation.

Chuan Hong: Thanks.

But in summary, OBCell continues to show what we believe to be best-in-class activity, with, a high level of sustained complete remissions in BNHL patients, without inducing severe cytokine release syndrome or any neurotoxicity.

Christian Itin: Yeah, thanks, Chuan.

<unk>.

In B cell non Hodgkin's lymphoma, and primary CNS lymphoma presented by way of a poster each as well as an oral presentation of the first Ottawa 'twenty two phase one data in pediatric <unk> patients at that event.

Good question.

So what we did see, obviously, with Auto4, is we did see the clinical responses and we also did see nicely expanded cartilage and CAR-T cells in the actual tumor lesions.

I'll cover these data in the upcoming slides.

That's data that we shared at the conference.

Slide 12.

What we did not see is elevated levels of CAR-T cells, in the periphery.

As a reminder, the academic old car 19 study has been extended as a basket study testing <unk> in a variety of B cell malignancies to date, we've treated 17 patients with Follicular lymphoma.

Obviously, we can detect the CAR-T cells, but we don't see significant elevated levels.

Now, this is not too uncommon if you have also, depending on looking at the EOBCL patients, as an example, you can also have patients that actually do show complete remission without actually showing any significant increase in level of CAR-T cells.

Now, what we're expecting to do with the changes, in the manufacturing process is really to help us in this patient pool, which obviously has, where we're collecting cells from the patient that could also potentially include lymphoma cells. The first step in the manufacturing processes, you actually have to get removed cells that potentially could also include lymphoma cells.

Lymphoma, <unk> and mantle cell lymphoma, and no patient experienced high grade Crs and none have any grade of neurotoxicity.

In this particular case, we're removing CAR-Tc1 positive cells.

So we start actually with a reduction of cells, at the first step, and then we go into the manufacturing process.

Of the 70 patients dosed 16 achieved a metabolic complete remission, 7% or seven follicular lymphoma patients six of seven <unk> patients and three a fleet mantle cell lymphoma patients.

So the process is somewhat different, than what you normally would use.

And what we're gonna do is adjust the process, such that we can actually run the process in a shorter period of time.

And that may actually have an impact, on some of the cell behavior, as we've seen in some of the other programs as well.

Whether that ultimately will show a difference, in terms of the T-cells we see in vivo formed in these patients or not, I think that remains to be seen.

We lost one patient to covet and one mantle cell lymphoma patient relapsed.

14 of the 16 patients remain in metabolic CR with a median follow up of $9 two months the longest being 19, one months and follow up at the last data cut and obviously the data will continue to mature and will give us more insights as we go forward with.

We've also started treating some CLI patients and from the three patients that have reached initial evaluation to rent into molecular CR in the bone marrow, but have some residual lymphadenopathy on CD scan we.

So we expect that data to become available of this initial cohort during probably the middle, of next year.

We expect to have follow up data from this old car extension study again in the second half of this year.

In addition, we have now seen first activity in primary CNS lymphoma patients.

And that also then actually gives us then the basis for moving the program forward.

Turning to slide 13, we're also exploring Ob sell in primary CNS lymphoma, and our academic Carousel study. This is a type of aggressive b cell lymphoma, but because of its anatomical location. It has been particularly it has a particularly poor prognosis initial treatment is also an intensive and outcomes for these patients tends to be poor.

In terms of prioritization, you're correct.

This is frankly an experiment, that actually hasn't been done.

We have obviously quite a set of interesting, opportunities we're building to.

The key focus is going to be on delivering OVCell and get OVCell to market.

It's a, you know, there's no real precedent, that I think we can build on here.

That's clearly where the primary focus of the organization is.

But it'll be interesting to look at that, and hopefully it's something we're gonna do now.

And the data we presented a DHA, we didn't see high grade cytokine cytokine release syndrome, two patients experienced neurotoxicity grade three and grade four respectively. One patient improved for steroids and Anakinra. The second patient had several neurological deficits consistent with progressive disease and did not respond to steroids.

Yep, that's very helpful.

Thanks.

Thanks, Tom.

On the kindred.

Overall, you can see on the right hand side of this slide that despite these patients having no disease outside of the CNS and having had lots of rituximab treatment, we still see really nice expansion of obesity in peripheral blood and we expect to provide more data from this study in 2023.

All right.

Moving to slide 14.

Our initial experience with Ob sell in children achieved a high level of sustained complete remissions, while without experiencing high grade cytokine release syndrome.

That's very much.

For those children, who relapsed most had lost CD 19 expression their leukemic cells at the time of relapse.

Beyond OBCell, we have seen first and promising results from the dual-targeting AutoWOMP22, program in children with acute lymphoblastic leukemia who are ineligible for chimeria therapy.

Operator: Now I'd like to turn it back to Olivier for closing remarks.

But there will be opportunities as we go through the course of next year to actually look at advancing some of the earlier programs, including Auto-122 as well as Auto-4, which I think both of them will start reaching interesting data points during the course of next year.

We're taking the next step.

In Ob sells lifecycle with <unk> 22, a dual targeting product building or b cell and adding a highly potent CD 22 targeting comerica antigen receptor.

Christian Itin: All right.

And I think will become programs that can be forwarded.

So, at that point in time, thank you.

So this is Christian.

Thank you very much.

CD 22 car was designed to be active against the cubic cells with low levels of CD 22 expression on their surface.

Thanks, Kelly.

Evaluated over 122, and an extension of the <unk> study in children, who are ineligible for <unk> <unk>.

All right, next up, we have Chuan Hong from J.P. Morgan.

Stand by, and you're- Hi, this is Chuan.

Children, either relapsed after receiving Kim Ryan I could not be retreated or they had extra medullary disease, a singular lesions in tissue without having disease in the bone marrow the normal location all of acute leukemia.

Hi, this is Chuan Hong for Eric Joseph.

Thanks for taking our question.

So, just a follow-up on the Auto4 program.

This is a very challenging group of patients to treat out of 11 children four had prior <unk> therapy and three of them had lost CD 19 expression seven of the children extra medullary disease move.

I'd like to thank everyone for joining, and for taking the time for today's update.

So, since the updates are ehaa, are there any new interpretation of the lack of Auto4 expansion in the peripheral?

Moving to slide 15.

And do you expect the product made, from the modified manufacturing process to have an impact on the 4-cell phenotype and expansion potential?

Data were presented at <unk> in an oral presentation that showed that nine of the 11 patients achieved a molecular CR on day 28.

<unk> hundred 92 was well manageable with no patients experienced high grade cytokine release syndrome, no patient relapsed with antigen loss and two of the CD 19 negative patients achieved a molecular complete remission demonstrating the isolated activity of the CD 22 car.

We're looking forward to seeing you, and keeping you updated on what's gonna be an exciting second half of the year for us.

We continue to follow the patients and we will update you later in the year.

Thank you.

Moving to slide 17.

The conference will begin shortly.

So, yeah, that's it.

Here is a brief depiction of our broad cell programming toolkit, we developed over the last few years all in the technologies cover programming modules for targeting control shielding and enhancing car T cell activity.

To raise your hand during Q&A, you can dial star 1-1.

Operator: The conference will begin shortly.

Operator: Itin, Simon Baker, Matthew Phipps, Gil Blum, James Shin, Asthika Goonewardene, Sebastiaan Shoot, Anas Younes, Claire Roddie, Julia Wilson, Edgar Braendle, Robert Dolski, Marie Leandro, Eric Yeung, Autolus Therapeutics PLC, This is a production of the Center for Autism and Related Disorders So on slide two before we begin I would just like to remind you that during today's call, our discussion will contain forward-looking statements.

Thanks.

Please make sure you are familiar with this disclosure slide.

Good, thanks, Chuan.

On slide three you should see the agenda for today which is as follows.

Good question.

More than 100 patent families covering our product and sell programming technologies recent illustrations of three technology applications were shown at <unk> annual meeting in May.

Each one of our product candidate applies one or several of the technologies to maximize its impact on the specific cancer. It is designed to tackle.

Christian will provide an overview of our operational highlights for the second quarter of 2022.

Moving to slide 18.

Lucinda will then discuss the company's financial results before Christian will conclude with the upcoming milestones and any other concluding comments and will then turn over for Q&A.

This slide shows more of our next generation programs beyond the <unk> program. We're excited about is order for which is in phase one study in T cell lymphoma, I'll give you an update of the data we presented at EHR in just a minute during.

The data presented at EHA we believe are demonstrating clinical proof of concept with, a high level of activity and a well-manageable safety profile. We're particularly excited about AutoIV reaching clinical proof of concept in patients with, peripheral T-cell lymphoma, reaching metabolic CRs while maintaining a well-manageable safety profile. This data validates a novel targeting approach, which is very important given the high unmet, need in this difficult-to-treat patient population.

So, what we did see, obviously, with Auto4, is we did see the clinical responses, and we also did see a nicely expanded, CAR T-cells in the actual tumor lesions.

With the two new programs reaching clinical proof of concept, our pipeline beyond OBCell, is advancing well, and we're pleased with how it's shaping up.

Olivia Manser: I'll now hand over to Christian to begin the presentation.

That's data that we shared at the conference.

What we did not see is elevated levels of CAR T-cells, in the periphery.

Finally, we're pleased in the quarter to dose our first patient in the Phase I study, AutoVIII, for the treatment of patients with relapsed refractory multiple myeloma, and are also on track for AutoVI-NG, our first solid tumor program, to start a Phase I in the second half of the year.

Thank you Olivia and good morning to you all and thank you for joining us.

Obviously, we can detect the CAR T-cells, but we don't see significant elevated levels.

During the first quarter as I mentioned already moved into the clinic in a phase one clinical study in multiple myeloma patients and we're now dosing patients I also want to reiterate.

Now, this is not too uncommon if you have also, depending on looking at the OBCL patients, as an example, you can also have patients that actually do show complete remissions without actually showing any significant increase in level of CAR T-cells.

First solid tumor program <unk> in <unk> positive solid tumors will be moving into the clinic second half of this year. This program has a clinically derisked chimeric antigen receptor <unk> and contains multiple programming modules to enhance its activity.

Now, what we're expecting to do with the changes, in the manufacturing process is really to help us in this patient pool, which obviously has, where we're collecting cells from the patient that could also potentially include lymphoma cells. The first step in the manufacturing process, is you actually have to get removed cells that potentially could also include lymphoma cells.

Turning to slide 19.

We're actively exploring T cell lymphoma, which is an aggressive disease with a very poor prognosis for patients you might recall, our EAA analyst call of Dr. Horowitz from the Department of Medicine Lymphoma service at Memorial Sloan Kettering Cancer Center talked about the majority of patients being either refractory or relapsing after initial.

In this particular case, we're removing CAR T-cells.

So we start actually with a reduction of cells, at the first step, and then we go into the manufacturing process.

So the process is somewhat different, than what you normally would use.

And what we're gonna do is adjust the process, such that we can actually run the process in a shorter period of time.

And that may actually have an impact, on some of the cells as we've seen in some of the other programs as well.

<unk>.

Whether that ultimately will show a difference, in terms of the T-cells we see in vivo formed in these patients or not, I think that remains to be seen.

Standard of care is variable and often based on intensive chemotherapy treatment.

This is frankly an experiment, that actually hasn't been done.

It's a, you know, there's no real precedent, that I think we can build on here.

But it'll be interesting to look at that, and hopefully it's something we're gonna be about.

Yep, that's very helpful.

Median survival for patients with relapsed or refractory disease is less than six months.

Thanks.

T cell lymphomas, or <unk> diseases that either express trp's, one or <unk>.

Thanks, Tom.

The T cell receptor beta chain constant domain, one or two or short TWC or TWC too are expressed on more than 95% of all T cell lymphoma subtypes.

All right.

The lymphoma derived from gamma Delta T cells, or NK T cells, lack CIBC monarch TWC too.

That's very much.

<unk> targets <unk> and is the first product candidate to do so using next generation sequencing, we identified patients with CIBC, one expressing T cell lymphoma.

Now I'd like to turn it back to Olivia, for closing remarks.

These CIBC one positive patients are then treated on the currently open order for study and in the future. We plan to open a study targeting <unk> two positive patients with auto five as well.

All right.

Auto for.

Is designed to selectively kill lymphoma cells in a manner that we believe will preserve a portion of the patients normal healthy T cells to maintain immunity.

So this is Christian.

Turning to slide 20 today.

To date, we've treated 10 patients with increasing doses of order for in the so called Libra <unk> study, we evaluated four dose levels ranging from 25 million cells to 450 million cells and have seen no dose limiting toxicities and only mild type of opinions.

In terms of cytokine release syndrome, which is sold one grade III cytokine release syndrome at the highest dose level sort of four was generally very well tolerated.

We've seen metabolic complete remissions in five of the seven evaluable patients with three of three patients at 450 million cell dose achieving a metabolic CR.

Two of the complete remissions at 450 million cell level are ongoing at three and six months.

And we expect to have longer follow up on these patients in the second half of this year.

Moving to slide 22 the.

The build of our commercial manufacturing facility in Stevenage is progressing on track, and within schedule, and I'll cover that in more detail later in the presentation.

The manufacturing of cell therapies is complex and requires a great deal of skill and experience. We are building a new manufacturing facility in Stevenage in the UK dislocation is about a mile from our current clinical manufacturing operation.

Moving to slide five.

<unk> facility and will allow us to transition our entire operation, including our experienced staff to the new facility and an expeditions and efficient way, both minimizing startup risks and costs for the commercial supply.

As evidenced by our successful manufacturing of car T products for the pivotal study with centers across the U S and Europe . The location is well suited for global supply with easy access to several international airports, including London's Heathrow.

The new 70000 square foot facility will provide <unk> with a capacity of approximately <unk> <unk> cell therapy batches, a year with the ability to expand further when needed.

Can see on this slide a rendering of what the facility will look like once completed by the end of the year. We're on track to commence GMP operations in mid 2023.

Clinical supply operations. We currently operate with four shifts seven days a week, our commercial manufacturing model will continue.

I'd like to thank everyone for joining, and for taking the time for today's update.

We're looking forward to seeing you, and keeping you updated on what's gonna be an exciting second half of the year for us.

Seven day, a week pattern for the 365 days a year.

With that, let's focus on our lead product, OBCell, and move to slide six. Just to remind you, OBCell has a unique mechanism of action built on a highly specific engagement, of CD19, coupled with a fast release from CD19 once the kill of the leukemic cell has been initiated. This fast disengagement is based on the fast off-rate of the cat binder, and drives three, key properties of OBCell. Reduction of the amount of cytokine release per target cell encounter, which in turn will, reduce the amount of immunotoxicity in the patients, reduced exhaustion in the CAR-T cell, and improved engraftment and overall persistence of OBCell, the product.

With that.

We're moving to slide 24, and I'd like to pass over to the center for our second quarter 2022 financial update with Cigna.

And those of you not familiar, I refer you to a paper by Sarah Garoshian at Nature Medicine in 2019.

Thank you.

Thanks, Christian and good morning, or good afternoon to everyone.

Moving to slide seven, there still remains a very high unmet medical need for adult ALL patients with approximately 8,400 new cases diagnosed yearly worldwide in the last line setting. Approximately 3,000 patients of these cases reside in the US and Europe. While combination chemotherapy enables 90% of adult ALL patients to achieve CRS, to achieve CRs, complete remissions, only 30% to 40% will achieve long-term remission. Once relapsed, patients have a median overall survival of less than a year.

It's my pleasure to review our progress for the second quarter in 2022.

Current approved, therapies for adult patients are glincito and anticartus.

Anticartus is currently approved in the US and has a favorable CHMP opinion in Europe, and it's expected to be approved in Europe later in the year. Both therapies are highly active, but frequently followed by subsequent treatments, typically including ALLO stem cell transplants.

Glincito has a favorable safety profile with few patients experiencing severe cytokine release syndrome and ICANS, but with limitations on convenience due to the need for continuous IV infusion during its four-week treatment cycles.

My pleasure to review our financial results for the second quarter to June 2028.

Anticartus is more challenging to manage and induces elevated levels of severe CRS, high level of ICANS or neurotoxicity, and requires steroids and vasopressors for many patients to manage adverse events.

Please move to slide number four.

Both therapies have been shown to be highly active.

For those who are new to Autolus and as a refresher for those of you who know us well we're building a fully integrated CAR-T company. Building on our broad platform of cell programming technologies we're generating CAR-T products that are tailored to the specific tumor setting we're addressing.

However, most patients progress rapidly and require subsequent allograft to achieve durability.

We had a successful quarter with multiple readouts from our clinical programs at the European Hematology Association Congress in Vienna in June which give us a great confidence in the inherent value of our pipeline and the progress, achieved.

We continued in the second quarter of 2022 salary search and development assets on our lead product candidate <unk>.

We continue to enroll patients into the Pivotal Felix trial where we're investigating ob-cell for the treatment of relapsed refractory adult acute lymphoblastic leukemia patients and in April we obtained a regenerative medicine advanced therapy or RMAT designation from the FDA. As a consequence we now have preferred regulatory access for ob-cell in all key territories the US, Europe and the UK and have met with the FDA in the context of a type b meeting to discuss the regulatory pathway going forward.

As well as assessing a pipeline asset, which I think helps us with limited treatment option.

Moving to slide eight.

Building on its unique mechanism of action, OVCell has shown a high overall response rate with a favorable safety profile and sustained, event-free survival that tracks long-term persistence in those patients.

Cash at June 30 is 22 totaled $216 $4 million asking.

As mentioned before, OVCell has been granted orphan drug designation by the FDA and EMA for ALL and obtained prime designation by EMA for the EU, ILAP designation by the MHRA for the UK, and most recently, RMAT designation by the FDA for the US.

Moving to slide nine.

Based on what we believe is potentially a transformational data from the OLCAR study, we are treating patients – we're conducting the pivotal FELIX study trial with approximately 90 patients in the so-called morphological cohort. We're treating currently patients at 34 sites across the US, the UK, and Spain.

We're on track with our previous guidance and expect to announce initial results in the fourth quarter this year, which will be in the shape of a press release.

As compared to cash of $310 $2 million at December 31, 2021.

We're planning on presenting full data at a medical conference in the first half of 2023, as indicated, currently thinking about ASCO.

Total operating expenses for the three months ended June 30, <unk> was $46 $5 million as compared to total operating expenses, which.

In order to maximize outcomes from the FELIX trial, in parallel, we've initiated an additional cohort of up to 50 patients in the second or later complete remission – in second or later complete remission.

We have minimal residual disease, so-called MRD-positive patients.

Net income in license revenue of $1 $6 million of 30.

$37 7 million for the same period in 2021.

However, this additional cohort does not impact our planned filing timelines, as the primary data will be based on the data from the morphological cohort.

Moving to slide 10 and switching gears as we're moving into slide 11.

Research and development expenses increased by $6 1 million to $38 2 million coming from.

OBCell's unique profile means it could be applicable to a broad range of indicators. We're consequently evaluating the product outside of acute lymphoblastic leukemia in, B-cell non-Hodgkin's lymphomas in a set of ongoing Phase I clinical studies.

As I mentioned, we have positive clinical readouts at the recent EHA Congress from Phase, I studies in B-cell non-Hodgkin's lymphoma and primary CNS lymphoma, presented by way of a poster each, as well as an oral presentation of the first OTA-122 Phase I data in pediatric, ALL patients at that event, and I'll cover these data in the upcoming slides.

Thats, a $2 $1 million.

Three months ended June 32016, as compared to the same period in 'twenty one.

Slide 12.

As a reminder, the academic All-Coron-19 study has been extended as a basket study where, we're testing OBCL in a variety of B-cell malignancies.

The net increase in research and development expenses of $6 $1 million, primarily due to the following.

To date, we've treated 17 patients with follicular lymphoma, DLBCL, and mantle cell lymphoma, and no patient experienced high-grade CRS, and none had any grade of neurotoxicity. Of the 17 patients dosed, 16 achieved a metabolic complete remission, 7 of 7 follicular lymphoma, patients, 6 of 7 DLBCL patients, and 3 of 3 mantle cell lymphoma patients. We lost 1 patient to COVID and 1 mantle cell lymphoma patient relapsed. 14 of the 16 patients remain in metabolic CR with a median follow-up of 9.2 months, the longest being 19.1 months in follow-up at the last data cut, and obviously the data will continue to mature and will give us more insights as we go forward.

We've also started treating some CLL patients, and from the 3 patients that have reached, initial evaluation, 2 went into molecular CR in the bone marrow but have some residual lymphadenopathy on CT scan.

We expect to have follow-up data from this ALL-CAR extension study again in the second, half of this year.

Turning to slide 13, we're also exploring OB cell in primary CNS lymphoma in our academic, CARO cell study.

This is a type of aggressive B-cell lymphoma, but because of its anatomical location, it, has a particularly poor prognosis. Initial treatment is often intensive, and outcomes for these patients tends to be poor.

In the data we presented at EHA, we didn't see high-grade cytokine release syndrome. Two patients experienced neurotoxicity, grade 3 and grade 4, respectively. One patient improved for steroids and anakinra.

The second patient had several neurological deficits consistent with progressive disease, and did not respond to steroids and anakinra.

An increase in clinical costs and manufacturing costs, primarily related to the clinical product candidates, the chinas $3 $5 million.

Overall, you can see on the right-hand side of this slide that despite these patients, having no disease outside of the CNS and having had lots of rituximab treatment, we still see really nice expansion of OB cell in peripheral blood, and we expect to provide more data from this study in 2023.

An increase of $1 $4 million in salaries and other employment related costs, including share based compensation expense, mainly driven by an increase in employees engaged in R&D activity.

An increase of $1 $4 million in legal and professional consulting fees in relation to the company's R&D activity in.

An increase of $5 million related to information technology infrastructure and support for information systems related to clinical trial and manufacturing operations.

And these increases were offset by decreases.

<unk> ability.

Related to the termination of patient companies such as.

17 months and shift.

<unk> strategy.

The decrease of $2 million in depreciation and amortization related to property plant and equipment and intangible assets.

Moving to general and administrative expenses these increased by $1 $1 billion to $8 3 million for the three months ended June <unk> 2019, compared with $7 $2 million.

Three months ended June 21, primarily due to the following.

An increase of $1 $3 million in salaries and other employment related costs will finish and compensation expenses.

An increase of $1 million primarily related to higher.

Obviously insurance premiums as well as certain professional fees in connection technologies.

And again these increases are offset by a decrease of $10 million incentive controlling contamination by the company assessing recently in the prior year and decreased $1 million and depreciation and amortization for nitrogen pumps and equipment and intangible assets.

Other expense net decreased by half a million dollars to $1 3 million for three months ended June 30th.

Some $1 $8 million for the three months ended June 'twenty, one relating primarily due to the strengthening of the U S dollar exchange rate relative to the pound Sterling.

Interest expense increased $1 8 million for the three months ended June 30th entity and relates to the liability relates to future royalties and sales milestones, which events upon the company's entry into the strategic cooperation and financing agreement with Fox and the 2020 months.

Yes, there was no interest expense during the comparable period in 2021.

Income tax benefit increased by $1 1 million to $7 $5 million for three months ended June 30, 'twenty came from $6 $4 million to the three months ended June 30th 21, due to an increase in quantifying R&D expenditures for the quarter.

Net loss attributable to ordinary shareholders was $42 1 million for three.

370 gene therapy, <unk> as compared to $33 $2 million for the same periods in 'twenty one.

The basic and diluted net loss per ordinary share.

The period ended June .

<unk> intends to title.

For $6 or 46 cents per share compared to a basic and diluted net loss per ordinary share.

47.

For the three months ended June 30th Central lung.

<unk> estimates that its current cash on hand, including anticipated milestone payments for Blackstone extend the cash the companys cash runway into 2024.

And with that I'll conclude my remarks, and toss back to Christian to give you a brief outlet unexpected loss thing Chris.

Moving to slide 14, our initial experience with OB cell in children achieved a high level, of sustained complete remissions while without experiencing high-grade cytokine release syndrome. For those children who relapsed, most had lost CD19 expression on their leukemic cells, at the time of relapse.

Here we're taking the next step in OB cell's life cycle with Auto-122, a dual-targeting, product building an OB cell and adding a highly potent CD22-targeting chimeric antigen receptor. The CD22 CAR was designed to be active against leukemic cells with low levels of CD22 expression, on their surface.

Christian.

We evaluated Auto-122 in an extension of the CAR-PALS study in children who were ineligible, for chimeria. The children either relapsed after receiving chimeria and could not be retreated, or they, had extra medullary disease, i.e. single lesions in tissue without having disease in the bone marrow, the normal location of acute leukemia. This is a very challenging group of patients to treat. Out of 11 children, 4 had prior chimeria therapy, and 3 of them had lost CD19 expression. 7 of the children had extra medullary disease.

Thanks, Lucy moving to slide 26.

We're getting to next steps we do believe we have an exciting period ahead of ahead of us with Ob cell in relapsed refractory adult male outpatient reaching readout of the pivotal field study starting in Q4 2022, and then obviously as we indicated earlier planning on presenting the full data at a medical conference in the first half of next year.

Moving to slide 15.

We're on track to announce the initial results for the Felix trial in Q4 2022 which will be provided by way of a press release and we're planning on presenting the full data set at a medical conference in mid-2023 most likely at ASCO.

Data were presented at EHA in an oral presentation and showed that 9 of the 11 patients achieved, a molecular CR on day 28.

As previously announced in addition to the primary morphological cohort in the Felix trial we have expanded the MRT cohort to enroll up to 50 patients.

In clinical practice patients get evaluated on a regular basis for recurrence of disease typically using flow analysis or PCR of their bone marrow samples. Indication of minimal residual disease levels of leukemia triggers treatment of the patients, rather than waiting for full-blown morphological relapse to occur.

<unk>.

We're also.

Cited to sort of engage obviously.

More intense interactions with the FDA.

As mentioned before that we had.

A very positive meeting a type b meeting with the FDA.

Auto-122 was well manageable, with no patients experiencing high-grade cytokine release syndrome.

In the context of the hardened that process now.

The studies of <unk> cel in relapsed refractory NHL CLO and primary.

No patient relapsed with antigen loss, and 2 of the CD19 negative patients achieved a, molecular complete remission, demonstrating the isolated activity of the CD22 CAR.

CNS lymphoma are ongoing.

As well as our older 122 program and our <unk> four program and do you expect to have more data over the course of this year next as I mentioned, we dosed our first patient in our multi myeloma study, we look forward to our <unk> getting started in neuroblastoma.

We will continue to follow the patients, and we'll update you later in the year.

Moving to slide 17.

Here is a brief depiction of our broad cell programming toolkit we developed over the, last few years. All in, the technologies cover programming modules for targeting, control, shielding, and enhancing CAR T cell activity. More than 100 patent families cover our products and cell programming technologies. Recent illustrations of 3 technology applications were shown at ASGCT annual meeting in May.

Each one of our product candidates applies one or several of the technologies to maximize, its impact on the specific cancer it is designed to tackle.

And finally as a result of our collaboration with Blackstone in anticipation of the milestones we expect to receive we do have and maintain a cash runway that sees us into 2024.

Moving to slide 18.

This slide shows more of our next-generation programs beyond OBCell.

We're now at the point, where we're happy to take questions. So operator, please let's start the Q&A.

A program we're excited about is Auto-4, which is in phase 1 study in T cell lymphoma.

Thank you very much all right now time for the Q&A portion.

I'll give you an update of the data we presented at EHA in just a minute.

In order to help your hand range and get in line. Please press star one on your telephone and you will be answered in the order received our first question.

During the first quarter, as I mentioned, Auto-8 moved into the clinic in a phase 1, clinical study in multiple myeloma patients, and we're now dosing patients.

I also want to reiterate first solid tumor program Auto-6NG in GD2 positive solid tumors, will be moving into the clinic second half of this year. This program has a clinically de-risked comedic antigen receptor to GD2 and contains multiple, programming modules to enhance its activity.

Is from <unk>.

Mara Goldstein.

Mizuho.

So standby.

Okay.

Yes.

Alright.

It will be up any secondhand.

Mara Europe .

Great. Thank you can you hear me, yes, we can awesome. Thanks, Hi.

Turning to slide 19, we're actively exploring T cell lymphoma, which is an aggressive disease, with a very poor prognosis for patients.

With respect to the timing on that study how does that line up with.

Our filings rate potentially and then just to circle back on the RMS and the meetings that <unk> had with FDA.

At this point on what's the next interaction with them and how does manufacturing also fit into that discussion.

Yes, very good question and thanks for joining so the <unk> cohort.

We will obviously continue.

Rolling into into next year.

Our plan is to file for a BLA towards the end of next year as well.

We have data.

From those patients that we can actually support them the results the ability as we're going into the BLA review process to update also on clinical data will give us an opportunity to add some additional data there as well. So we will definitely have information on that cohort.

A reasonable level of follow up but I think it's important to understand that the primary.

This additional cohort does not impact our planned filing timelines as the primary data will be based on the data from the morphological cohort however we do believe the MRT cohort will broaden the data set across the full range of tumor burden and align with current clinical practice.

Data that will actually drive and approval of the product will come from the morphological cohort. So the data from the <unk> cohort will be supportive.

We remain fully focused on generating the data package needed to file for BLA approval for ob-cell for the treatment of adult patients with acute lymphoblastic leukemia and remain confident in ob-cell's potential to be a best-in-class treatment in a growing market.

As I mentioned EHA was a very busy meeting for us with data readouts from multiple clinical programs and I'll go into more detail about the specific data later in this presentation, presentation.

Our supplemental in that sense, it will not be the primary data program.

But in summary, OVCEL continues to show what we believe to be best-in-class activity with a high level of sustained complete remissions in BNHL patients without inducing severe cytokine release syndrome or any neurotoxicity.

In addition, we have now seen first activity in primary CNS lymphoma patients.

Beyond OVCEL, we have seen first and promising results from the dual-targeting AUTO1-22 program in children with acute lymphoelastic leukemia who are ineligible for chimeria therapy.

The data presented at EHA we believe are demonstrating clinical proof of concept with a high level of activity and a well-manageable safety profile. We're particularly excited about AUTO4 reaching clinical proof of concept in patients with, peripheral T-cell lymphoma, reaching metabolic CRs while maintaining a well-manageable safety profile. This data validates a novel targeting approach, which is very important given the high unmet need in this difficult-to-treat patient population.

With two new programs reaching clinical proof of concept, our pipeline beyond OVCEL is advancing well, and we're pleased with how it's shaping up.

The second part of your question was related to the engagement of the interactions with the FDA.

Finally, we're pleased in a quarter to dose our first patient in the phase one study, AUTO8, for the treatment of patients with elapsed refractory multiple myeloma and are also on track for AUTO6-NG, our first solid tumor program, to start a phase one in the second half of the year.

The build of our commercial manufacturing facility in Stevenage is progressing on track and within schedule, and I'll cover that in more detail later in the presentation.

What it can do under the <unk> designation is obviously you've got a.

Facilitated at simpler access to the agency.

Moving to slide five.

And the first key meetings that you've gone through these so called type user data and analyze it to do is really a review of the program.

With that, let's focus on our lead product, OVCEL, and move to slide six. Just to remind you, OVCEL has a unique mechanism of action built on a highly specific engagement, of CD19 coupled with a fast release from CD19 once the kill of the leukemic cell has been initiated. This fast disengagement is based on the fast off-rate of the cat binder and drives three, key properties of OVCEL. Reduction of the amount of cytokine release per target cell encounter, which in turn will reduce the amount of immunotoxicity in the patients, reduced exhaustion in the CAR-T cell, and improved engraftment and overall persistence of the product.

And those of you not familiar, I refer you to a paper by Sarah Garoshian at Nature Medicine in, 2019.

Moving to slide seven.

There still remains a very high unmet medical need for adult ALL patients with approximately 8,400 new cases diagnosed yearly worldwide in the last line setting. Approximately 3,000 patients of these cases reside in the U.S. and Europe.

Whilst combination chemotherapy enables 90% of adult ALL patients to achieve CRS, to achieve CRs, complete remissions, only 30% to 40% will achieve long-term remission. Once relapsed, patients have a median overall survival of less than a year.

Across its entire range that includes <unk>.

Current approved therapies for adult patients are Blincito and Ticardis. Ticardis is currently, approved in the U.S. and has received a favorable CHMP opinion in Europe, and it's expected to be approved in Europe later in the year.

Both therapies are highly active, but frequently followed by subsequent treatments, typically including ALLO stem cell transplant.

Manufacturing non clinical as well as the clinical side of the program. That's a very broad range of topics that you could cover within the type a meeting and actually start to get appropriate guidance et cetera. As you move forward. So that's sort of the way it start that.

Plans.

BlinCyto has a favorable safety profile with few patients experiencing severe cytokine, release syndrome and ICANs but with limitations on convenience due to the need for continuous IV infusion during its four-week treatment cycles.

Descartes is more challenging to manage, and induces elevated levels of severe CRS, a high level of ICANs or neurotoxicity, and requires steroids and vasopressors for many patients to manage adverse events.

Both therapies have been shown to be highly active.

Opportunities for interaction both as we move forward.

However, most patients progress rapidly, and require subsequent allograft to achieve durability.

Continue to actually address questions related to that.

Clinical data set but also separate set of track that actually then focuses more on the questions related to the CMC section.

Okay.

So both of those actually it will be ongoing.

The nice thing about <unk> is that it gets you into a collaboration with the agency.

Gives you an ability to really have a level of access.

During the process that is really helpful and support it.

Preparing for BLA and then also get into the review process.

Moving to slide eight.

Okay.

Building on its unique mechanism of action, OBCEL has shown a high overall response rate with a favorable safety profile and sustained event-free survival that tracks long-term persistence in those patients.

Thank you.

June .

Thank you Laura next up is Rob Andrews with William Blair standby.

Yeah.

Rob you're in.

As mentioned before, OBCEL has been granted orphan drug designation by the FDA and EMA for ALL and obtained prime designation by EMA for the EU, ILAP designation by the MHRA for the, UK, and most recently, RMAT designation by the FDA for the U.S. Moving to slide nine.

Okay. Good morning, this is Rob Andrew on for Matt.

Based on what we believe is potentially a transformational data from the OLCAR study, we are treating patients.

Thanks for taking my questions as well.

I will also fall the slide specifically called out one of the follow up in the second half should we assume that it's going to be additional patients therapy. You mentioned at the time of EHS <unk> date.

That you were implementing some manufacturing improvements those in place of clinical trial protocols now.

Currently being used in the trial and would you expect some data from patients treated with that product.

You might recall our EHA analyst call where Dr. Horwitz from the Department of Medicine, Lymphoma Service at Memorial Sloan Kettering Cancer Center talked about the majority of patients being either refractory or relapsing after initial treatment.

We're conducting the pivotal FELIX study trial with approximately 90 patients in the so-called morphological cohort. We're treating currently patients at 34 sites across the U.S., the UK, and Spain.

At the end of the year.

Standard of care is variable and often based on intensive chemotherapy treatment. Median survival for patients with relapsed or refractory disease is less than six months.

T cell lymphomas are clonal diseases that either express TRBC1 or TRBC2.

Well, thanks for joining Ralph.

The T cell receptor beta chain constant domain 1 or 2, or short TRBC1 or TRBC2, are expressed, on more than 95% of all T cell lymphoma supplements, types.

Only lymphomas derived from gamma-delta T cells or NKT cells lack TRBC1 or TRBC2.

You are correct, our SaaS we have the.

AUTO4 targets TRBC1, and it is the first product candidate to do so. Using next-generation, sequencing, we identify patients with TRBC1-expressing T cell lymphoma.

Presentations at the analyst call. Following the Ehi any day, we did point that back that we're going to.

Yeah.

Adjusted manufacturing process and actually some improvements into the manufacturing process that we're sort of.

Developed also originally in the context of the <unk> program that is ongoing.

Work is now available at the process can be used for the new patients coming in so we are actually in the process of actually manufacturing for patients with the <unk> manufacturing process, whether those patients and how many of those patients might be available by year end I think is too early to tell.

We're on track with our previous guidance and expect to announce initial results in the fourth quarter this year, which will be in the shape of a press release.

We're planning on presenting full data at a medical conference in the first half of 2023, as indicated, currently thinking about ASCO.

In order to maximize outcomes from the FELIX trial, in parallel, we've initiated an additional cohort of up to 50 patients in the second or later complete remission. We have minimal residual disease, so-called MRD-positive patients.

Just an analysis perspective, and how they can at a reasonable level of data but.

However, this additional cohort does not impact our planned filing timelines, as the primary data, will be based on the data from the morphological cohort.

Moving to slide 10 and switching gears as we're moving into slide 11, OBCell's unique profile means it could be applicable to a broad range of indications.

But we certainly expect during the course of next year. Joe is they have the full data for all that additional cohorts of patients.

That are treated with the <unk>.

Improved manufacturing process.

Okay, Great and then just on auto.

Yes.

The dual PGM ACD 19, I think the planet originally been to start with just the BCA may cost us the efficacy of dock car construct alone since it was a novel control before adding in CD 19 is that still the case and especially so would you expect the data in.

Second half of next year to be primarily the CMA car loan or some dual color as well.

So first of all your recollection is correct. This is a program that includes.

Two.

Targeting approaches one again.

The one against <unk> on the <unk> side, there is really the focus initially to test that novel and highly potent CMA car.

What we've done with this particular genetic average receptor is really optimize it against.

Multiple myeloma cells that carry very low levels of <unk> on their surface since a highly potent approach I would want to firstly the impact of the <unk> alone and then add on that as you pointed out the CD 19 car as we move forward I think making a prediction to kind of the type of data, we're going to be able to see at the end of next year, it's probably a bit premature.

We're starting to treat patients and have initiated.

Dosing patients now and we'll have to see.

Has it study progresses and how the data comes along but I think there should be a good chance for.

Great.

Thank you very instructive informative data set by the end of next year, but it is a dose escalation study and it is a phase one study so.

We'll have to see as we go through the course of the year to.

The nature of the data.

And at the end of next year.

Got it thanks for taking the questions.

Thanks, Rob.

Okay.

Yeah.

Brian .

Okay.

Alright. Thank our next question is from Bill with Jeremy Thank.

Your line. Thank you.

Go ahead with your question.

Hi, This is bill I'll monitor Oscar.

We just had a question about the auto eight program and some recent updates we saw over the summer we saw a great sells fast manufacturing update.

And we assume that there is a preferable phenotype.

VAG themselves as well along with their <unk>.

<unk> and we saw long term follow up with <unk>.

I think there's about a 10% differential in response rates between those two we were wondering what you think is the appropriate bar for auto it and we're hoping you could comment on discrete contract differences between the three.

Contracts.

Well first of all bill Thanks for joining I think interesting set of questions.

Obviously, we do know, Florida from the Carty two trial that we do have a very significant level of activity, we're seeing with program.

And obviously that are getting longer term observation of which look very encouraging I think will be a big improvement for this patient group.

The design of that product in terms of the way that we find that the binding.

Describe to the CMA, our two binders single domain buyers.

Seem to be acting in conjunction and provide a very tight very efficient binding to the CMA, which seems to be part of the mechanism that drives the high level of activity. So that's kind of what's driven.

On the buyback.

I think we'll have to OCC, where some of the other programs are getting too I think it's still early days for some of those I think what we focused on with our program is really to make sure. We do that is very high level of activity.

Again, these M&A expressing mouse model of ourselves and our case, obviously optimized.

Much of the buy rate sell off as well as in fact actually the actual construction of the car, which looks slightly different than what it is.

More broadly used in the space is quite a bit of optimization that when they traded assets from a molecular perspective the product groups.

It looks different from.

Allstate.

Our license J&J program in wholesale as far as the sales program.

But I think thats, probably what we do know at this point in time, and I think we need to see kind of how these programs shape up over time.

I think at that point I think we'll have more information to share.

Okay.

Thank you.

Thanks, a lot.

Thanks, Bill next up is Gil Blum with Needham <unk> company.

Standby.

Okay.

Thanks for taking our question.

Maybe a broader question first so given kind of the emerging data from five pacific's in B cell lymphoma.

We think there's still a lot of on us on developing novel T cell based therapeutics, particularly non Hodgkin lymphoma.

We're consequently evaluating the product outside of acute lymphoblastic leukemia in B-cell non-Hodgkin's lymphomas in a set of ongoing phase one clinical studies.

As I mentioned, we have positive clinical readouts at the recent EHA congress from phase one studies in B-cell non-Hodgkin's lymphoma and primary CNS lymphoma, presented by way of a poster each, as well as an oral presentation of the first OTA-122 phase one data in pediatric ALL patients at that event.

And I'll cover these data in the upcoming slides.

Slide 12.

As a reminder, the academic OLCAR-19 study has been extended as a basket study, where we're testing OBCell in a variety of B-cell malignancies.

It's a really interesting question Gil.

And I think what we do know I think we probably have the best data to sort of compare contrast activities and added problems OSA is in <unk>, where we do have buy side, though which is still the most active.

Bi specific T cell engagements that we have seen.

Right.

When we look at the activity between brand side, though and Ob sell there is a very significant level of difference that we do pick up.

In that setting and enterprise services.

Really comparable on the data set including the ability to provide long term.

<unk>, which serve.

The oversell data would suggest from the old car study.

Which is something that was not feasible or not that could help you demonstrated.

Title after the.

The model by specific business.

<unk> data is our bispecific for non Hodgkin's out they are interesting because in defense from that they might be able to combine with some of the other antibody mediated.

Our antibody based modalities and Thats, certainly kind of where the big play that you've seen play out with a number of companies I think it is interesting to note that.

Roche decided to enter into a year on cell therapy actually with a program that targets <unk>.

<unk>.

As well, so clearly going into the <unk> space, which before the.

The primary focus of the company while device specific.

<unk> felt that that's an area that we wanted to get into which to me. It certainly is interesting. It suggests that as we have.

And this space is it looks like the level of activity described by the initial khaki programs that came to market in <unk>.

Any of those turnarounds appears to be higher.

And potentially more sustained.

Compared to what we've seen to date on the bi specific well.

It's interesting, but it also seems to be emotion and it looks like some of the parties who have some very specific stakes into game seem.

<unk> consider it seems to go up.

In closing.

Going into into cell therapy.

And for that.

Considering we're expecting.

Quite a few updates across our team.

That form in the second half should.

Should we expect these presentations at ash or youre, not giving any guidance right now.

Yes, I think for the most part.

Okay.

Kind of the heap.

Segments of conferences, you got two time points typically in the year you got at the end of the year.

<unk> at the middle of the year that the European meeting the HIV and those are kind of the two primary events for data releases and certainly as we're looking for at the end of the year. The primary focus is going to be a match.

Okay.

These TRBC1-positive patients are then treated on the currently open AUTO4 study, and in the future, we plan to open a study targeting TRBC2-positive patients with AUTO5 as well.

And on out of four.

How would you.

Scribe the data that's evolving.

<unk> targeting car T when compared to data evolving from CB 708 targeting car Ts and the same indication.

AUTO4 is designed to selectively kill lymphoma cells in a manner that we believe will preserve a portion of the patient's normal healthy T cells to maintain immunity.

To date, we've treated 17 patients with follicular lymphoma, DLBCL, and mantle cell lymphoma, and no patient experienced high-grade CRS, and none had any grade of neurotoxicity. Of the 17 patients dosed, 16 achieved a metabolic complete remission, 7 of 7 follicular lymphoma patients, 6 of 7 DLBCL patients, and 3 of 3 mantle cell lymphoma patients. We lost one patient to COVID and one mantle cell lymphoma patient relapsed. Fourteen of the 16 patients remain in metabolic CR with a median follow-up of 9.2 months, the longest being 19.1 months in follow-up at the last data cut.

I think what we're seeing with our own data is that we're able to induce complete remissions at a pretty significantly elevated level. The more patients that will be I think.

Turning to slide 20.

And obviously the data will continue to mature and will give us more insights as we go forward.

To date, we've treated 10 patients with increasing doses of AUTO4 in the so-called LIBRA T1 study. We evaluated four dose levels ranging from 25 million cells to 450 million cells and have seen no dose-limiting toxicities and only mild cytopenias.

We've also started treating some CLL patients, and from the three patients that have reached initial evaluation, two went into molecular CR in the bone marrow but have some residual lymphadenopathy on CT scan.

We expect to have follow-up data from this all-car extensive study again in the second half of this year.

I think precise Orion is obviously very encouraging that the first three patients dosed the highest dose level to achieve the metabolic CR I think we're still continuing observer observation of the patients that achieved a CR to understand for how long. This can be maintained I think thats something we do not know yet at this point in time.

In terms of cytokine release syndrome, we just saw one grade three cytokine release syndrome at the highest dose level, so AUTO4 was generally very well tolerated.

And I think the data is very encouraging because we seem to be getting to that level of CR without inducing any significant level of toxicity, particularly where the eyes.

Inducing.

Yeah.

A major or having a major impact on the actual overall sub compartment.

We've seen metabolic complete remissions in five of the seven evaluable patients, with three of, three patients at 450 million cell dose achieving a metabolic CR. Two of the complete remissions at 450 million cell level are ongoing at three and six months, and we expect to have longer follow-up, on these patients in the second half of this year.

I would say are in a good.

Physician demand.

Maintain immunity in these patients so that looks really encouraging I think the date on CD 70 wishes.

Moving to slide 22.

The manufacturing of cell therapies is complex and requires a great deal of skill and experience. We're building a new manufacturing facility in Stevenage in the UK. This location is about a mile from our current clinical manufacturing operations at the so-called CGT facility and will allow us to transition our entire operation, including our experienced staff, to the new facility in an expeditious and efficient way, both minimizing startup risks and costs for the commercial supply.

As evidenced by our successful manufacturing of CAR T's products for the Pivotal study with centers across the U.S, and Europe, the location is well suited for global supply with easy access to several international airports, including London Heathrow. The new 70,000 square foot facility will provide all of us with a capacity of approximately 2,000 cell therapy batches a year, with the ability to expand further when needed.

You can see on this slide a rendering of what the facility will look like once completed by the end of the year.

We're on track to commence GMP operations in mid-2023.

I don't think we know enough about it at this point in time to really get a good feel for that data.

For our clinical supply operations, we currently operate with four shifts, seven days a week.

Our commercial manufacturing model will continue the seven-day-a-week pattern for, the 365 days a year.

But what.

What we do have with <unk> targeting is certainly a very unique way of targeting.

A very selective way of targeting T cells are being very focused on that population. So it will be.

And to see how some of these programs at both as a huge medical need.

These patients need desperately additional treatment options.

And they have a very I think.

Tiny devices.

Clearly with the CIBC long and we also expect EWC to providing and having two novel ways of actually going after this disease setting in a way that is oxy as well as well tolerated.

Turning to slide 13, we're also exploring ob-cell in primary CNS lymphoma in our academic CARO cell study.

This is a type of aggressive B-cell lymphoma, but because of its anatomical location, it has a particularly poor prognosis. Initial treatment is often intensive, and outcomes for these patients tends to be poor.

Thank you and last one for Lucy.

Moving to slide 14.

The second patient had several neurological deficits consistent with progressive disease and did not respond to steroids and anakinra.

Overall, you can see on the right-hand side of this slide that despite these patients having no disease outside of the CNS, and having had lots of rituximab treatment, we still see really nice expansion of ob-cell in peripheral blood, and we expect to provide more data from this study in 2023.

Can you provide any information on potential cadence of Blackstone milestone.

Particularly given that youre going to have a pivotal readout in the fourth quarter and finally in 2023.

Christian Itin: With that, we're moving to slide 24, and I'd like to pass over to Lucinda for our second quarter 2022 financial update.

Lucinda Crabtree: Lucinda?

Yes, I mean as you know we haven't.

Thanks, Christian, and good morning or good afternoon to everyone.

Typically broken out.

Doug milestone payments, but what we have said is that diesel ATT development and.

It's my pleasure to review our financial results for the second quarter to June 30, 2022.

We continued in the second quarter of 2022 to focus our research and development efforts on our lead product candidate OvoCell, as well as certain of our pipeline assets addressing cancers with limited treatment options.

Cash at June 30, 2022 totaled $216.4 million, as compared to cash of $310.3 million at December 31, 2021.

Total operating expenses for the three months ended June 30, 2022 were $46.5 million, as compared to total operating expenses, which was net income and license revenue of $1.6 million of $37.7 million for the same period in 2021. Research and development expenses increased by $6.1 million to $38.2 million from $32.1 million for the three months ended June 30, 2022, as compared to the same period in 21.

The net increase in research and development expenses of $6.1 million was primarily due to the following. An increase of $1.4 million in legal and professional consulting fees in relation to the company's R&D activities. An increase of $0.5 million related to information technology infrastructure and support for information systems related to the conduct of clinical trials and manufacturing operations. And these increases were offset by a decrease of $0.5 million in facility costs related to the termination and closure of the company's U.S. manufacturing facility in 2021 and shift in its manufacturing strategy. And also a decrease of $0.2 million in depreciation and amortization related to property, plant, and equipment and intangible assets.

<unk>.

Moving to general and administrative expenses, these increased by $1.1 million to $8.3 million for the three months ended June 30, 2022, compared with $7.2 million for the three months ended June 30, 2021, primarily due to the following. An increase of $1.3 million in salaries and other employment-related costs, including share-based compensation expenses.

And with that, I conclude my remarks and pass back to Christian to give you a brief outlook on expected milestones.

An increase of $0.1 million primarily related to higher directors' and officers' liability insurance premiums, as well as certain professional fees and information technology costs. And again, these increases were offset by a decrease of $0.2 million in facilities costs related to the termination by the company of certain lease agreements in the prior year and a decrease of $0.1 million in depreciation and amortization related to property, plant, and equipment and intangible assets.

Thanks, so read into that.

Other expense net decreased by $0.5 million to $1.3 million for the three months ended June 30, 2022, from $1.8 million for the three months ended June 30, 2021, relating primarily due to the strengthening of the U.S. dollar exchange rate relative to the pound sterling.

Interest expense increased to $1.8 million for the three months ended June 30, 2022, and relates to the liability related to sales of future royalties and sales milestones, which arose upon the company's entry into the strategic collaboration and financing agreement with Blackstone in November 2021.

There was no interest expense during the comparable period in 2021. Income tax benefit increased by $1.1 million to $7.5 million for the three months ended, June 30, 2022, from $6.4 million for the three months ended June 30, 2021, due to an increase in qualifying R&D expenditures for the quarter.

Thank you again.

Net loss attributable to ordinary shareholders was $42.1 million for the three months ended June 30, 2022, as compared to $33.2 million for the same period in 21. The basic and diluted net loss per ordinary share for the period ended June 30, 2022, totaled $0.46 or 46 cents per share, compared to a basic and diluted net loss per ordinary share of 47 cents for the three months ended June 30, 2021.

Autolus estimates that its current cash on hand, including anticipated milestone payments, from Blackstone, extends the company's cash runway into 2024.

Okay very helpful. Thank you for taking our questions and congrats on the progress.

Lucinda Crabtree: Thanks, Christian.

Thanks Bill.

Christian Itin: Thanks, Lucy.

Thank you Jim next up is Kelly <unk> from Jefferies.

Moving to slide 26, and we're getting to next steps. We do believe we have, an exciting period ahead of us with OBCell in relapsed refractory dulled ALL patients reaching readout of the pivotal Felix study starting in Q4, 2022.

The question is Paul.

Paul Pediatrics.

Could you share any color on the enrollment pace and is the focus only on quinoa you allocable patients.

Timeline youre targeting for the next phase of the study and also.

Curious which program.

Hawaii will be prioritized for internal pipeline development.

And our focus on commercialization of doubts.

<unk>.

Travel issue to be expected for the next 15 years. Thank you.

And then obviously, as we indicated earlier, planning on presenting the full data at a medical conference in the first half of next year.

We're also excited to sort of engage, obviously, in more intense with the FDA.

And I did mention before that we had a very positive meeting, a type B meeting with the FDA in the context of the RMAP process.

Yes, Thanks, Kelly really good question, so with regards to the.

The patient population whats been targeting in pediatric AML.

Obviously for the initial patients where we're going for.

In our case that had basically no option left to be to have access to.

<unk> therapy.

And that is certainly there.

Extra space at the study and also I'm curious which program.

Now, the studies of OBCell in relapsed refractory BNHL, CLL, and primary CNS lymphoma are ongoing, as well as our OTA-122 program and our OTA-4, program. And we expect to have more data over the course of this year and next.

Hawaii will be prioritized for internal pipeline development.

And our focus on commercialization of doubt.

<unk>.

Travel issue to be expected for the next 15 years. Thank you.

Yes, Thanks, Kelly really good question, so with regards to the.

As I mentioned, we dosed our first patient in our multiple myeloma study.

We look forward to OTA-6NG getting started in neuroblastoma. And finally, as a result of our collaboration with Blackstone and anticipation of the milestones we expect to receive, we do have and maintain a cash runway that sees us into 2024.

The patient population whats been targeting in pediatric AML.

Obviously for the initial patients where we're going for.

In our case that have basically has no option left to be to have access to.

Therapy.

And that is certainly the case with children, who are sort of past beyond patients and what we could demonstrate is obviously a very high level of activity good safety and with that I think have.

Our initial experience with ob-cell in children achieved a high level of sustained complete permissions, without experiencing high-grade cytokine release syndrome. For those children who relapsed, most had lost CD19 expression in their leukemic cells at the time of relapse.

Here we're taking the next step in ob-cell's life cycle with ODA-122, a dual-targeting product building an ob-cell and adding a highly potent CD22-targeting chimeric antigen receptor. The CD22 CAR was designed to be active against leukemic cells with low levels of CD22 expression on their surface.

We evaluated ODA-122 in an extension of the CAR-PAL study in children who were ineligible for chimeria. The children either relapsed after receiving chimeria and could not be retreated, or they had extra-medullary disease, i.e. single lesions in tissue without having disease in the bone marrow, the normal location of acute leukemia. This is a very challenging group of patients to treat. Out of 11 children, 4 had prior chimeria therapy, and 3 of them had lost CD19 expression. 7 of the children had extra-medullary disease.

Sort of established kind of the basic profile of the product.

Moving to slide 15.

As we go forward I think there is opportunity to also enrolled patients will be eligible.

That becomes a possibility as we start to move forward.

The selling of key activities that we're engaged in and that program is also too.

There are some modifications on the manufacturing process as well and kind of actually.

We'll explore that.

<unk> group with additional patients.

I think that dataset will then actually through that formed the basis for any decision.

On moving the program forward, so we expect that data to become available.

This initial cohort.

During.

Probably the middle of next year and that also then actually gives us and the basis for moving the program forward in terms of prioritization.

You are correct, we have obviously quite a set of interesting opportunities for building too.

The key focus is going to be on delivering a reselling adobe sell through market, that's clearly where the primary focus of the organization is.

There will be opportunities that we go through the course of next year to actually.

Looked at advancing some of the earlier program.

<unk> auto answer to is what was over four which I think both of them will start reaching.

Interesting data points.

During the course of next year.

We'll be comp programs.

Having fully developed at that point in time.

We're now at the point where we're happy to take questions.

Thank you very much thanks.

Thanks, Kevin.

Okay.

Christian Itin: So, operator, please let's start the Q&A.

Alright next up we have chuan Hong from J P. Morgan.

Sam.

Thank you very much.

This is Sean.

All right.

Hi, This is Sean on for Eric Joseph Thanks for taking our question. So just a follow up on the <unk> four.

Operator: Now time for the Q&A portion.

Our program. So I think the update on <unk> are there.

A presentation of the lack of Alco for expansion in the portfolio.

And do you expect that product made from the modified manufacturing process to have an impact.

Parallel.

Expansion potential.

So yes, that's it thanks.

Okay. Thanks, good question.

So what we did see obviously, we in order for it is we did see the clinical responses that will sustain.

Let's see.

Nicely expanded.

Car T cells in the actual.

Tumor lesions.

Data that we shared at the conference. We did not have not see is elevated levels of car T cells in the periphery. Obviously, we can we can protect.

<unk> car T cells, but we don't see significant elevated levels now.

Now to our common if you have also depending on booking.

Bcl patients as an example.

Could also have patients that actually do show.

Complete remission without actually showing any significant increase in level of car T cells now what we're expecting to do with the.

The changes in the manufacturing process is really to help us.

In this patient pool, which obviously.

Has.

Collecting patient cells from the patient that could also potentially include.

For myself the first step in the manufacturing processes do you actually have to get remove cells that potentially could also include lymphoma ourselves in this particular case, where we're moving <unk>.

So if we start actually with a reduction of sales in the first step in that regard to the manufacturing process.

This is somewhat different than what you normally would use what we can do is adjust the process such that we can actually volumes are in the process.

In a short period of time and that May actually have an impact on some of the sale of the data.

As we've seen in some of the other programs as well.

Whether that ultimately will show a difference in terms of.

The T cells, we see in vivo formed in these patients. So I think that remains to be seen. This is frankly, an experiment that actually hasn't been salvage there.

There is no greater presence.

They will come here.

But it will be interesting to look at that then illustrate how it has helped me we're going to do that.

That's very helpful. Thanks.

Thanks, Sean.

Alright.

Very much I'd like to turn it back to Olivier for closing remarks.

Alright. So this is Christian.

Like to thank everyone for joining.

For him to take the time for today's update and we're looking forward to keeping you posted Meanwhile, and CEO probably back in September numbers, and Meanwhile, for those of you can get away I wish you a great summer break.

Get some rest and we're looking forward to seeing you and keep you updated on what's going to be an exciting second half of the year for us. Thank you.

Operator: In order to have your hand raised and get in line, please press star 11 on your telephone and you will be answered and the order received.

Data were presented at EHA in an oral presentation and showed that 9 of the 11 patients achieved a molecular CR on day 28. ODA-122 was well manageable, with no patients experiencing high-grade cytokine release syndrome. No patient relapsed with antigen loss, and 2 of the CD19-negative patients achieved a molecular complete remission, demonstrating the isolated activity of the CD22, to CAR.

The conference will begin shortly to raise your hand during Q&A you can dial one one.

[music].

Hello, ladies and gentlemen, and welcome to the analyst therapy.

<unk> second quarter 2022 financial results Conference call. As a reminder, this conference call is being recorded.

Towards the end of the call. We will have a Q&A portion if you would like to be put in the queue first come first serve press star one one and at that time, you will be called upon to ask your question without further Ado I would like now to turn the conference over to your host Olivia Mansour Director Investor Relations Olivia.

Thanks.

Thanks, Corey good morning.

Hello, everyone and thank you for joining us and stay cool on the financial results and operational highlights for the second quarter.

<unk>.

Hum.

Relations and with me on the call Christian Hi, Jen.

<unk> Executive officer.

Lucinda Crabtree, our Chief Financial Officer.

Operator: Our first question is from Mara Goldstein at Mizuho.

We will continue to follow the patients and will update you later in the year.

On slide two before we begin.

Mind, you that during today's call our discussion will contain forward looking statements. Please make sure you are familiar with this slide.

So, stand by.

Moving to slide 17.

Yep.

All right.

Mara will be up any second here.

Here is a brief depiction of our broad cell programming toolkit we developed over the last few years. All in, the technologies cover programming modules for targeting, control, shielding, and enhancing CAR T cell activity. More than 100 patent families cover our product and cell programming technologies. Recent illustrations of three technology applications were shown at ASGCT annual meeting in May.

Operator: Mara, you're up.

Each one of our product candidates applies one or several of the technologies to maximize its impact on the specific cancer it is designed to tackle.

Great.

Moving to slide 18.

Mara Goldstein: Thank you.

This slide shows more of our next generation programs beyond OBCell.

A program we're excited about is Auto IV, which is in phase one study in, T cell lymphoma. I'll give you an update of the data we presented at EHA in just a minute.

During the first quarter, as I mentioned, Auto VIII moved into the clinic in a phase, one clinical study, multiple myeloma patients, and we're now dosing patients.

I also want to reiterate first solid tumor program, Auto VI-NG in GD2 positive solid tumors will be moving into the clinic second half of this year. This program has a clinically de-risked comedic antigen receptor to GD2 and contains multiple programming modules to enhance its activity.

Turning to slide 19.

We're actively exploring T cell lymphoma, which is an aggressive disease with a very poor prognosis for patients.

You might recall our EHA analyst call where Dr. Horwitz from the Department of Medicine Lymphoma Service at Memorial Sloan Kettering, Cancer Center talked about the majority of patients being either refractory or relapsing after initial treatment.

Standard of care is variable and often based on intensive chemotherapy treatment. Median survival for patients with relapsed or refractory disease is less than six months.

T cell lymphomas are clonal diseases that either express TRBC1 or TRBC2. The T cell receptor beta chain constant domain one or two or short TRBC1 or TRBC2 are expressed on more than 95% of all T cell lymphoma subtypes.

Only lymphomas derived from gamma delta T cells or NK T cells lack TRBC1 or TRBC2.

Auto IV targets TRBC1 and is the first product candidate to do so.

Using next generation sequencing, we identify patients with TRBC1 expressing T cell lymphoma. These TRBC1 positive patients are then treated on the currently open Auto IV study and in the future, we plan to open a study targeting TRBC2 positive patients with Auto V as well.

Auto IV is designed to selectively kill lymphoma cells in a manner that we believe will preserve a portion of the patient's normal healthy T cells to maintain immunity.

Turning to slide 20.

To date, we've treated 10 patients with increasing doses of Auto IV in the so-called Libra T1 study. We evaluated four dose levels ranging from 25 million cells to 450 million cells and have seen no dose limiting toxicities and, In terms of cytokine release syndrome, we just saw one grade three cytokine release syndrome at the highest dose level, so the four was generally very well tolerated.

Particularly excited about auto for reaching clinical proof of concept in patients with peripheral T cell lymphoma, reaching metabolic crs, while maintaining a bell manageable safety profile.

This data validates a novel targeting approach, which is very important given the high unmet need in this difficult to treat patient population.

With two new programs, reaching clinical proof of concept our pipeline beyond the Ob cell is advancing well and we're pleased with how it's shaping up.

Finally, we're pleased in the quarter to dose our first patient in the phase one study of <unk> eight for the treatment of patients with relapsed refractory multiple myeloma and all.

It's on track for order fixed <unk>, our first solid tumor program to start a phase III in the second half of the year.

The build of our commercial manufacturing facility in Stevenage is progressing on track with its schedule.

With that in more detail later in the presentation.

Can you hear me?

We've seen metabolic complete remissions in five of the seven evaluable patients, with, three of three patients at 450 million cell dose achieving a metabolic CR. Two of the complete remissions at 450 million cell level are ongoing at three and six months, and we expect to have longer follow-up on these patients in the second half of this year.

Moving to slide five.

With that let's focus on our lead product Ob sale and move to slide six just to remind you <unk> has a unique mechanism of action and built a highly specific engagement of CD 19, coupled with a fast release from CD 19 wants to kill Leukemic cell has been initiated.

Operator: Yes, we can.

Moving to slide 22.

The manufacturing of cell therapies is complex and requires a great deal of skill and experience.

We're building a new manufacturing facility in Stevenage in the U.K. This location is about a mile from our current clinical manufacturing operation at the so-called, CGT facility, and will allow us to transition our entire operation, including our experienced staff, to the new facility in an expeditious and efficient way, both minimizing startup risks and costs for the commercial supply.

Awesome.

This fast this engagement is based on the past offering to the cat Binder and drive three key properties of Ob cell reduction of the amount of cytokine release for target selling character, which in turn will reduce the amount of immediate toxicity of the patients reduced exhaustion in the car T cell and improved and graph and over.

Persistence of the product.

Thanks.

And those of you not familiar I refer you to a paper by Sarah Russia at nature Medicine in 2019.

Hi.

As evidenced by our successful manufacturing of CAR-T's products for the pivotal study, with centers across the U.S. and Europe, the location is well-suited for global supply with easy access to several international airports, including London Heathrow. The new 70,000-square-foot facility will provide all of us with a capacity of approximately, 2,000 cell therapy batches a year, with the ability to expand further when needed.

You can see on this slide a rendering of what the facility will look like once completed, by the end of the year.

Moving to slide seven.

There still remains a very high unmet medical need for adult AML patients with approximately 8400, new cases diagnosed yearly worldwide in the last slide setting approximately 3000 patients of these cases resided in the U S and Europe .

With respect to the timing on the MRD study, how does that line up with BLA filing potentially?

Mara Goldstein: And then just to circle back on the RMAT and the meetings that you've had with FDA, from this point on, what's the next interaction with them, and how does manufacturing also fit into that discussion?

Christian Itin: Yeah, very good question, Mara, and thanks for joining.

This combination chemotherapy enables 90% of adult AML patients to achieve Crs.

<unk> complete remissions, only 30% to 40% will achieve long term remission.

Once relapsed patients have a median overall survival of less than a year.

We're on track to commence GMP operations in mid-2023.

Current approved therapy for adult patients with late cycle and the Carters and <unk> is currently approved in the U S. And has received a favorable <unk> opinion in Europe and is expected to be approved in Europe later in the year.

For our clinical supply operations, we currently operate with four shifts, seven days a week.

Our commercial manufacturing model will continue the seven-day-a-week pattern for the 365 days, a year.

Our therapies are highly active but frequently followed by subsequent treatments typically including allo stem cell transplants.

This is more challenging to manage and reduces elevated levels of severe crs.

High level of icons of neurotoxicity and require steroids and base of presses for many patients to manage adverse events.

Both therapies have been shown to be highly active however, most patients progressed rapidly and require subsequent allograph to achieve durability.

With that, we're moving to slide 24, and I'd like to pass over to Lucinda for our second, quarter 2022 financial update.

Moving to slide eight.

Building on its unique mechanism of action <unk> has showed a high overall response rate with favorable with a favorable safety profile and sustained of entry survival that tracks long term persistence in those patients.

As mentioned before or we sell has been granted orphan drug designation by the FDA and EMA for ALLL at obtained prime designation by EMA for the EU ILEC designation by the MH array for the U K and most recently, our Mac designation by the FDA for the U S moving.

Lucinda?

Moving to slide nine.

Thanks, Christian, and good morning, or good afternoon, to everyone.

Based on what we believe is potentially a transformational data from the old car study we are trading pace. We're conducting the pivotal field study trial with approximately 90 patients in the so-called morphological cohort. We're treating currently patients at 34 sites across the U S. The UK and Spain.

Or if you think of that <unk>.

In order to maximize outcomes for the Felix trial in parallel we've initiated an additional cohort of up to 50 patients in the second related complete remission.

So the MRD cohort will obviously continue enrolling into next year.

In second or later complete remission, we have minimal residual disease. So called MRP positive patients. However, this additional court does not impact our planned filing timelines as the primary data will be based on the data from the morphological cohort.

Our plan is to file for BLA towards the end of next year, so we will certainly have data from those patients that we can actually support, and then there's obviously an ability as we're going into the BLA review process to update also on clinical data, and that will give us an opportunity to add on some additional data there as well.

So we'll definitely have information on that cohort with a reasonable level of follow-up.

It's my pleasure to review our financial results for the second quarter to June 30, 2022.

Moving to slide 10.

And switching gears.

I think it's important to understand that the primary data that will actually drive an approval of the product will come from the morphological cohort, so the data from the MRD cohort will be supportive or supplemental in that sense.

We continued in the second quarter of 2022 to focus our research and development efforts, on our lead product candidate, OvoCell, as well as certain health pipeline assets, addressing cancers with limited treatment options.

Cash at June 30, 2022 totaled $216.4 million, as compared to cash of $310.3 million at December, 31, 2021.

As we move into slide 11.

Total operating expenses for the three months ended June 30, 2022 were $46.5 million, as, compared to total operating expenses, which was net income and license revenue of $1.6 million, of $37.7 million for the same period in 2021. Research and development expenses increased by $6.1 million to $38.2 million from $32.1, million, so the three months ended June 30, 2022, as compared to the same period in 21.

The net increase in research and development expenses of $6.1 million was primarily due, to the following. An increase in clinical costs and manufacturing costs primarily related to the oversold clinical product candidate to the tune of $3.5 million.

An increase of $1.4 million in salaries and other employment-related costs, including share-based compensation, expense, which is mainly driven by an increase in the number of employees engaged in R&D An increase of $1.4 million in legal and professional consulting fees in relation to the company's, R&D activities.

An increase of $0.5 million related to information technology infrastructure and support for information systems related to the conduct of clinical trials and manufacturing operations. And these increases were offset by a decrease of half a million dollars in facility costs related to the termination and closure of the company's U.S. manufacturing facility in 2021 and shift in its manufacturing strategy.

And also a decrease of $0.2 million in depreciation and amortization related to proxy plant and equipment and intangible assets.

Moving to general and administrative expenses, these increased by $1.1 million to $8.3 million, for the three months ended June 30, 2022, compared with $7.2 million for the three months ended June 30, 2021, primarily due to the following. An increase of $1.3 million in salaries and, other employment-related costs, including share-based compensation expenses.

An increase of $0.1 million primarily related to higher directors and officers' liability insurance premiums, as well as certain professional fees and information technology costs. And again, these increases were offset by a decrease of $0.2 million in facilities costs related to the termination by the company of certain lease agreements in the prior year and a decrease of $0.1 million in depreciation and amortization related to proxy plant and equipment and intangible assets.

Interest expense increased to $1.8 million for the three months ended June 30, 2022, and relates, to the liability related to sales of future royalties and sales milestones, which arose upon the company's entry into the strategic collaboration and financing agreement with Blackstone in November 2021.

There was no interest expense during the comparable period in 2021. Income tax benefit, increased by $1.1 million to $7.5 million for the three months ended June 30, 2022, from $6.4 million for the three months ended June 30, 2021, due to an increase in qualifying R&D expenditures for the quarter.

Net loss attributable to ordinary shareholders was $42.1 million for the three months ended June 30, 2022, as compared to $33.2 million for the same period in 2021. The basic and diluted net loss per ordinary share for the period ended 30 June 22 totaled, $0.46 or $0.46 per share, compared to a basic and diluted net loss per ordinary share of $0.47 for the three months ended June 30, 2021.

Autolus estimates that its current cash-on-hand, including anticipated milestone payments from, Blackstone, extends the company's cash runway into 2024.

And with that, I conclude my remarks and pass back to Christian to give you a brief outlook on expected milestones.

Thanks, Christian.

<unk>.

B cell non Hodgkin's lymphoma, and primary CNS lymphoma presented by way of a poster each as well as an oral presentation of the first Ottawa 'twenty two phase one data in pediatric <unk> patients at that event.

It will not be the primary data for review.

Thanks, Lucy.

Cover these data in the upcoming slides.

Slide 12.

The second part of the question was related to the engagement and the interactions with the FDA.

Moving to slide 26, and we're getting to next steps.

As a reminder, the academic old car 19 study has been extended as a basket study where brake testing or we sell it in a variety of b cell malignancies to date, we've treated 17 patients with Follicular.

So what you can do under the RMAC designation is also you get a facilitated and simpler access to the agency, and the first key meeting that you run through is the so-called type B meeting, and what that allows you to do is really review the program across its entire range, so that includes manufacturing, non-clinical, as well as the clinical side of the program.

We do believe we have an, exciting period ahead of us with Obicel in relapsed refractory dulled ALL patients reaching readout of the pivotal FELIX study starting in Q4 2022, and then obviously, as we indicated earlier, planning on presenting the full data at a medical conference in the first half of next year.

So it's a very broad range of topics that you can cover within the type B meeting and actually start to get appropriate guidance, et cetera, as you move forward.

So that's sort of the way it starts out.

Lymphoma, <unk> and mantle cell lymphoma, and no patient experienced high grade Crs and <unk> had any grade of neurotoxicity.

There's then obviously opportunities for interaction both as you move forward to continue to actually address questions related to the clinical data set, so a separate set of track that actually then focuses more on the questions related to the CFC section of the BLA.

So both of those actually will be ongoing, and the nice thing about an RMAC is that it gets you into a collaborative setting with the agency and gives you the ability to really have a level of access during the process that is really helpful and supportive, not just in preparing for BLA and then also getting to the review process.

Okay.

Of the 70 patients dosed 16 achieved a metabolic complete remission seven of seven Follicular lymphoma patients six of seven bcl patients and three of three mantle cell lymphoma patients.

Thank you.

Thank you, Mara.

Operator: Next up is Rob Andrews with William Blair.

We lost one patient to covet and one mantle cell lymphoma patient relapsed.

14 of the 16 patients remain in metabolic CR with a median follow up of $9 two months, the longest being 19.1 months and follow up at the last data cut and obviously the data will continue to mature and we will give us more insights as we go forward.

We're also excited to sort of engage, obviously, in more intense interactions with the FDA, and, I did mention before that we have a very positive meeting, a type B meeting with the FDA in the context of the RMAP process.

Now, the studies of Obicel in relapsed refractory BNHL, CLL, and primary CNS lymphoma are ongoing, as well as our Auto-122 program and our Auto-4, program, and we expect to have more data over the course of this year and next.

As I mentioned, we dosed our first patient in our multiple myeloma study.

We look forward to Auto-6NG getting started in neuroblastoma. And finally, as a result of our collaboration with Blackstone and anticipation of the milestones we expect to receive, we do have and maintain a cash runway that sees us into 2024.

We're now at the point where we're happy to take questions.

We expect to have follow up data from this old car extension study again in the second half of this year.

Stand by.

So, operator, please let's start the Q&A.

Turning to slide 13, we're also exploring Ob sale in primary CNS lymphoma, and our academic Carousel study. These are the type of aggressive b cell lymphoma that because of its anatomical location. It has been.

Thank you very much.

It has a particularly poor prognosis initial treatment is often an intensive and outcomes for these patients tends to be poor.

All right.

Now, time for the Q&A portion.

In order to have your hand raised and get in line, please press star 11 on your telephone, and you will be answered in the order received.

And the data we presented at <unk>, we didn't see high grade cytokine cytokine release syndrome, two patients experienced neurotoxicity grade three and grade four respectively. One patient improved for steroids and Anakinra. The second patient had several neurological deficits consistent with progressive disease and did not respond to steroids and anakinra.

Our first question is from Mara Goldstein at Mizuho.

Overall, you can see on the right hand side of this slide that despite these patients having now disease outside of the CNS and having had lots of Rituxan map treatment, we still see really nice expansion of Ob sale in peripheral blood and we expect to provide more data from this study in 2023.

Operator: And, Rob, you're in.

So, stand by.

Moving to slide 14.

Rob Andrews: Okay, good morning.

All right.

Mara will be up any second here.

Our initial experience with Ob selling children achieved a high level of sustained complete remissions.

Mara, you're up.

Without experiencing high grade cytokine release syndrome for.

Great.

For those children, who relapsed most had loss of CD 19 expression their leukemic cells at the time of relapse.

This is Rob Andrews.

Thank you.

We're taking the next step in.

In obese <unk> lifecycle with <unk> 22, a dual targeting product building or b cell and adding a highly potent CD 22 targeting comerica antigen receptor.

It fits here.

Can you hear me?

Thanks for taking our questions as well.

Yes, we can.

The CD 22 car was designed to be active against the cubic sales with low levels of CD 22 expression on their surface.

Rob Andrews: Just also for the slide specifically called out one, the follow-up in the second half, should we assume there's going to be additional patients there?

Awesome.

We evaluated over 122 and an extension of the <unk> study in children, who are ineligible for <unk>.

Thanks.

The children either relapsed after receiving Kim Ryan I could not be retreated or they had extra medullary disease, a singular lesions in tissue without having disease in the bone marrow the normal location all of acute leukemia.

Hi.

This is a very challenging group of patients to treat out of 11 children four had prior <unk> therapy and three of them had loss CD 19 expression seven of the children extra medullary disease.

Just with respect to the timing on the MRD study, how does that line up, with BLA filing potentially?

Moving to slide 15.

I think you mentioned at the time of EHA update that you were implementing some manufacturing improvements.

Data were presented at <unk> in an oral presentation that showed that nine of the 11 patients achieved a molecular CR on day 28.

You know, are those in place for clinical trial product now currently being used in the trial?

<unk> hundred 92 was well manageable with no patients experienced high grade cytokine release syndrome.

And would you expect some data from patients treated with that product in that update at the end of the year?

No patient relapsed with antigen loss and two of the CD 19 negative patients achieved a molecular complete remission demonstrating the isolated activity of the CD 22 car.

Christian Itin: Well, thanks for joining, Rob.

And then just to circle back on the RMAT and the meetings that you've had with FDA, you know, from this point on, what's the next interaction with them, and how does manufacturing also fit into that discussion?

We will continue to follow the patients and we will update you later in the year.

You're correct.

Yeah, very good question, Mara, and thanks for joining.

Moving to slide 17.

So, the MRD cohort will obviously continue enrolling into next year.

Our plan is to file for BLA towards the end of next year, so we will certainly have data, from those patients that we can actually support, and then there's obviously an ability as we're going into the BLA review process to update also on clinical data, and that will give us an opportunity to add on some additional data there as well.

More than 100 patent families cover our product and sell programming technologies recently illustrations of three technology applications were shown at <unk> annual meeting in May.

So, we'll definitely have information on that cohort with a reasonable level of follow-up, but I think it's important to understand that the primary data that will actually drive an approval of the product will come from the morphological cohort.

So, the data from the MRD cohort will be supportive or supplemental in that sense. It will not be the primary.

The second part of the question was related to the engagement and the interactions with, the FD&T.

What you can do under the RMAS designation is obviously you get a facilitated and simpler, access to the agency.

Each one of our product candidate applies one or several of the technologies to maximize its impact on the specific cancer. It is designed to tackle.

And the first key meeting that you run through is the so-called type meeting, and what that, allows you to do is really review the program across its entire range, so that includes manufacturing, non-clinical, as well as the clinical side of the program.

So it's a very broad range of topics that you can cover within the type meeting and, actually start to get appropriate guidance, et cetera, as you move forward.

So that's sort of the way it starts out.

There's then obviously opportunities for interaction both as you move forward to continue to actually, address questions related to the clinical data set, but also a separate set of tracks that actually then focuses more on the questions related to the CFC section of the BLA.

So both of those actually will be ongoing, and the nice thing about an RMAS is that it, gets you into a collaborative setting with the agency and gives you the ability to really have a level of access during the process that is really helpful and supportive as you are preparing for BLA and then also getting to the review process.

Okay.

Moving to slide 18.

This slide shows more of our next generation programs beyond the <unk> program. We're excited about is on a four which is in phase one study in T cell lymphoma, I'll give you an update of the data we presented at <unk> in just a minute.

I was asked, we had the presentations of the, analyst call, and following the EHA meeting, we did point out the fact that we're going to adjust the manufacturing process and actually set some improvements into the manufacturing process that were sort of developed also originally in the context of the OBCEL program.

Thank you.

That is ongoing.

Thank you, Mara.

So that work is now available, and the process can be used for the new patients coming in.

Next up is Rob Andrews with William Blair.

During the first quarter as I mentioned already moved into the clinic in a phase one clinical study in multiple myeloma patients and we're now dosing patients I also want to reiterate.

Stand by.

And Rob, you're in.

Okay.

Turning to slide 19.

We're actively exploring T cell lymphoma, which is an aggressive disease with a very poor prognosis for patients you might recall, our EAA analyst call over Dr. Horowitz from the Department of Medicine Lymphoma service at Memorial Sloan Kettering Cancer Center talked about the majority of patients being either refractory or relapsing after initial.

Treatment.

Standard of care is valuable and often based on intensive chemotherapy treatment.

Median survival for patients with relapsed or refractory disease is less than six months.

T cell lymphomas, or <unk> diseases that either express trp's, one or <unk>.

The T cell receptor beta chain constant domain, one or two or short TWC, while <unk> are expressed on more than 95% of all T cell lymphoma subtypes.

The lymphoma derived from gamma Delta T cells, or NK T cells, lack CIBC longer TWC too.

For the four targets TWC, one and he is the first product candidate to do so using next generation sequencing, we identify patients with <unk> expressing T cell lymphoma.

These CIBC one positive patients are then treated on the currently open order for study and in the future. We plan to open a study targeting <unk> two positive patients with auto five as well.

Order for.

Is designed to selectively kill lymphoma cells in a manner that we believe will preserve a portion of the patients normal healthy T cells to maintain immunity.

Turning to slide 20 today.

To date, we've treated 10 patients with increasing doses of order for in the so called Libra <unk> study, we evaluated four dose levels ranging from 25 million sales to 450 million cells and have seen no dose limiting toxicities and only mild type of opinions.

In terms of cytokine release syndrome, which is sold one grade three cytokine release syndrome at the highest dose level sort of four was generally very well tolerated.

We've seen metabolic complete remissions in five of the seven evaluable patients with three of three patients at 450 million cell dose achieving a metabolic CR.

Two of the complete remissions at 450 million cell level are ongoing at three and six months.

And we expect to have longer follow up on these patients in the second half of this year.

Moving to slide 22 the.

So we are actually in the process of actually manufacturing for patients with the new manufacturing process.

Whether those patients and how many of those patients might be available by year end, I think, is too early to tell from just an analysis perspective and having a reasonable level of data around them.

The manufacturing of cell therapies is complex and requires a great deal of scale and experience. We're building a new manufacturing facility in Stevenage in the UK. This location is about a mile from our current clinical manufacturing operations at the so called CGT facility and will allow us to transition our entire operation, including our experienced staff to the new facility.

But we certainly expect during the course of next year, if you will, to have the full data from that additional cohort of patients that are treated with the improved manufacturing process.

Okay, great.

Rob Andrews: And then just on auto aid, you know, Piak kind of noted the dual BCMA CD19, design.

I think the plan had originally been to start with just the BCMA car to test the efficacy of that car construct alone, since it was a novel construct before adding in CD19.

Rob Andrews: Is that still the case?

And I suppose if so, would you expect the data in the second half, of next year to be primarily BCMA car alone or some dual car as well?

<unk> and an expeditions and efficient way, both minimizing startup risks and costs for the commercial supply.

Christian Itin: So first of all, your recollection is correct.

The new 70000 square foot facility will provide <unk> with a capacity of approximately <unk> <unk> cell therapy batches, a year with the ability to expand further when needed.

Can see on this slide a rendering of what the facility will look like once completed by the end of the year. We're on track to commence GMP operations in mid 2023.

Clinical supply operations. We currently operate with four shifts seven days a week, our commercial manufacturing model will continue.

Seven day, a week pattern.

For the 365 days a year.

This is a program that includes two targeting, approaches, one against BCMA, the other one against CD19. On the BCMA side, there's really the focus initially to test that novel and highly potent BCMA car.

With that.

We're moving to slide 24, and I'd like to pass over to the center for our second quarter 2022 financial update with Cigna.

What we've done with this particular chromatic atherogen receptor is really optimize it against multiple myeloma cells that carry very low levels of BCMA on the surface.

Good morning.

Thanks, Christian and good morning, or good afternoon to everyone.

So it's a highly potent approach, and we want to first see the impact of the BCMA car alone, and then add on, as you pointed out, the CD19 car as we move forward.

This is Rob Andrews.

I think making a prediction to kind of the type of data we're going to be able to see at the end of next year is probably a bit premature.

My pleasure to review our financial results for the second quarter to June 2028.

We're starting to treat patients or have initiated dosing patients now, and we'll have to see how the study progresses and how the data comes along.

But I think there should be a good chance for a very instructive and informative data set by the end of next year.

But it is a dose escalation study, and it is a very advanced study.

Rob Andrews here.

We continued in the second quarter of 2022 salary search and development assets on our lead product candidate <unk> as.

So we'll have to see, as we go through the course of the year, kind of better feel for the nature of the data we'll be able to present at the end of next year.

As well as assessing a pipeline asset, which I think helps us with limited treatment option.

Cash at June 30 is 22 totaled $216 million.

As compared to cash.

<unk> $10 2 million at December 31, 2021.

Total operating expenses for the three months ended June 32.

2019, with $46 $5 million as compared to total operating expenses.

Which was net income of license revenue of $1 6 million a 30.

$37 7 million for the same period in 2021.

Research and development expenses increased by $6 1 million.

To $38 2 million coming from.

$32 $1 million.

The three months ended June 32016, as compared to the same period in 'twenty one.

The net increase in research and development expenses of $6 $1 million, primarily due to the following.

An increase in clinical costs and manufacturing costs, primarily related to the clinical product candidates, the chinas $3 5 million and.

An increase of $1 $4 million in salaries and other employment related costs, including share based compensation expense, mainly driven by an increase in number of employees in Houston R&D activity.

An increase of $1 $4 million in legal and professional consulting fees in relation to the company's R&D activity and.

An increase of $5 million related to information technology infrastructure and support transmission system related to the conduct of clinical trials marketing operations.

And these increases were offset by decreases.

Got it.

Costs related to the termination of the company.

Centene.

And shift almost matching strategy.

Also a decrease of $2 million in depreciation and amortization related to property plant and equipment and intangible assets.

Yes.

Moving to general and administrative expenses these increased by $1 $1 billion to $8 3 million for the three months ended June <unk> 2022, compared with <unk> 15.

And then Jim question 21, primarily due to the following.

An increase of $1 $3 million in salaries and other employment related comfortable taking share based compensation expenses.

An increase of $1 million primarily related to higher.

Obviously as liability insurance premiums as well as certain professional fees.

And again these increases were offset by a decrease of $2 million incentive costs related to the termination by the company assessing lease agreement prior year decreased $2 1 million.

<unk> million dollars.

Depreciation and amortization related to property plant and equipment and intangible assets.

Okay.

Other expense net decreased by half a million dollars to $1 $3 million for three months ended June 30th towards 'twenty.

One $8 million for the three months ended June 'twenty, one relating primarily due to the strengthening of the U S dollar exchange rate relative to the pound Sterling.

Interest expense increased to $1 8 million for the three months ended June 30th entity and relates to the liability relates to sales and future royalties and sales milestones, which events on the company's entry into the strategic cooperation and financing agreement with Blackstone in the 2020 months.

There was no interest expense during the comparable period in 2021.

Income tax benefit increased by $1 1 million to $7 $5 million for three months ended June 32018 from $6 4 million for the three months ended June 30, 'twenty, one due to an increase in quantifying R&D expenses for the quarter.

Net loss attributable to ordinary shareholders was $42 1 million for three months ended June 30 of 17 as compared to $33 $2 million for the same periods in 2001.

The basic and diluted net loss per ordinary share.

And the period ended associates SG&A such two titles.

For $6, a foot six cents per share compared to a basic and diluted net loss per ordinary share.

<unk> 47.

The three months ended June 30th Central lung.

Thanks for taking our questions as well.

<unk> estimates that its current cash on hand, including anticipated milestone payments for Blackstone extend the cash the companys cash runway into 2024.

Great.

And with that I conclude my remarks, and pass back to Christian to give you three outlet on expected loss.

Thanks for taking the questions.

Just also for the slide specifically called out one, the follow-up in the second half, should we assume there's going to be additional patients there?

Christian.

Thanks, Lucy I'm moving to slide 26.

We're getting to next steps, we do believe we have an exciting period ahead of ahead of us with Ob cell.

In relapsed refractory adult male outpatient reaching readout of the pivotal field study starting in Q4 2022, and then obviously as we indicated earlier planning on presenting the full data at a medical conference in the first half of next year.

We're also.

Excited to sort of engage all the same.

More intense interactions with the FDA and I did mention before that we had.

A very positive meeting a type b meeting with the FDA.

In the context of the <unk> process.

The studies of <unk> in relapsed refractory NHL CLO and primary.

CNS lymphoma are ongoing.

As well as our <unk> two program and our <unk> program and we expect to have more data over the course of this year and next as I mentioned, we dosed our first patient in our multiple myeloma study, we look forward to our <unk> getting started in neuroblastoma.

And finally as a result of our collaboration with Blackstone in anticipation of the milestones we expect to receive we do have and maintain a cash runway that sees us into 2024.

We're now at the point, where we're happy to take questions. So operator, please let's start the Q&A.

Thank you very much all right now time for the Q&A portion.

In order to help your hand range and get in line. Please press star one on your telephone and you will be answered in the order received our first question.

Is from <unk>.

<unk> Goldstein.

Mizuho.

So standby.

Yes.

Alright.

It won't be up any secondhand.

Mara Europe , great. Thank you can you hear me, yes, we can hi.

Thanks, everyone.

With respect to the timing on that study how does that line up with.

Filing potentially.

And then just to circle back on the RMS and the meetings that <unk> had with FDA.

From this point on what's the next interaction with them and how does manufacturing also fit into that discussion.

Yes, very good question and thanks for.

Joining so the <unk> cohort.

We'll obviously continue.

Rolling into into next year.

Our plan is to file for a BLA towards the end of next year as well.

We have data.

From those patients that we can actually support them the results the ability effort going into the BLA review process to update also on clinical data and that will give us an opportunity to add on some additional data there as well. So we will definitely have information on that cohort.

A reasonable level of follow up but I think it's important to understand that the prime rate.

Data that will actually drive and approval of the product will come from the morphological cohort. So the data from the <unk> cohort will be supportive.

Our supplemental in that sense, it will not be the primary data for revenue.

The second part of your question was related to the engagement of the interactions with the FDA.

What it can do under the <unk> designation is obviously you've got a.

Facilitated at simpler access to the agency.

And the first key meetings that you've gone through these so called type year to date and what that allows you to do is really a review of the program.

Across its entire range that includes.

Manufacturing non cleanup call as well as the clinical side of the program. That's a very broad range of topics that you could cover within the type a meeting and actually you start to get appropriate guidance et cetera. As you move forward, so thats sort of the way it started that Daniel.

Opportunity for interaction both.

We move forward too.

To actually address questions related to the clinical data, but also separate.

<unk> actually been focusing more on the questions related to the CMC section all of Eni.

So both of those actually it will be ongoing.

The nice thing about <unk> is that it gets you into a collaboration with the agency.

Gives you an ability to really have a level of access.

During the process that is really helpful and support it.

We are preparing for a BLA and then also get into the review process.

Okay.

Thank you.

June .

Thank you Laura next up is Rob Andrews with William Blair standby.

Yeah.

Rob you're in.

Okay. Good morning, this is Rob Andrew on for Matt.

Bye-bye.

Operator is next.

Operator: I think our next question is from Bill with Truist, and it looks like, your line's open.

Thanks.

All questions as well just.

I will also fall the slide specifically called out one of the follow up in the second half should we assume that it's going to be additional patients. There I think you mentioned at the time of EHS <unk> date.

I think you mentioned at the time of EHA update that you were implementing some manufacturing, improvements.

That you are implementing some manufacturing improvements are those in place of clinical trial protocols now currently being used in the trial and would you expect some data from patients treated with that product.

Are those in place for clinical trial products now currently being used in the trial?

And would you expect some data from patients treated with that product in that update at, the end of the year?

Okay at the end of the year.

Operator: I think our host may be on mute, so Bill, go ahead with your question.

Well, thanks for joining, Rob.

Well, thanks for joining Ralph.

You're correct.

I would say as we had the presentations of the analyst call following the EHA meeting, we did point out the fact that we're going to adjust the manufacturing process and actually set some improvement into the manufacturing process that was sort of developed also originally in the context of the OB cell program.

Youre correct.

Yes, we have.

Presentations at the analyst call that following the EHS <unk> date, we did point that back that we're going to.

Adjusted manufacturing process and actually some improvements into the manufacturing process.

Developed also originally in the context of the Ob cell program that is ongoing.

That is ongoing.

So that work is now available and the process can be used for the new patients coming in.

Work is now available at the process can be used for the new patients coming in so we are actually in the process of actually manufacturing for patients with a new manufacturing process, whether those patients and how many of those patients might be available by year end I think it is too early to tell.

So we are actually in the process of actually manufacturing for patients with the new manufacturing, process.

Whether those patients and how many of those patients might be available by year end, I, think is too early to tell from just an analysis perspective and having a reasonable level of data around them.

From an analysis perspective, and how they can at a reasonable level of data on them, but we certainly expect during the course of next year. You. Obviously have the full data for all that additional cohorts of patients.

But we certainly expect during the course of next year's dose to have the full data, from that additional cohort of patients that are treated with the improved manufacturing process.

That are treated with the <unk>.

<unk> manufacturing process.

Okay, great.

Okay, Great and then just on auto.

And then just on auto A, you know, I kind of noticed the dual BCMA CD19 design. I think the plan had originally been to start with just the BCMA car to test the efficacy of that car construct alone since it was a novel construct before adding in CD19.

Yes kind of notice.

Dual became ACD 19 does that I think the planet originally been to start with just the BCA may cost us the efficacy of Dot com alone.

Is that still the case?

Mobile contract before adding in CD 19 is that still the case and especially so would you expect the data in.

Second half of next year to be primarily be CMA Carlo awesome dual color as well.

So first of all your recollection is correct. This is a program that includes.

Two.

Targeting approaches.

The other one against <unk> on the <unk> side. There is really the focus initially to test that novel highly potent CMA cart will be done with this particular genetic average receptor is really optimize it against multiple myeloma cells that carry very low levels of <unk> on the surface.

And I suppose if so, would you expect the data in the second half of next year to be primarily BCMA car alone or some dual car as well?

It's a highly potent approach I would want to firstly the impact of the <unk> alone and then add on that as you pointed out the CD 19 car as it was.

Going forward I think.

Making a prediction to kind of the type of data, we're going to be able to see at the end of next year is probably a bit premature.

Sure.

We're starting to treat patients that have to have initiated dosing patients now and we'll have to see how that study progresses and how the data comes along but I think there should be a good chance for.

Okay.

Thank you very instructive informative dataset by the end of next year, but it is a dose escalation study.

Phase one studies.

We'll have to see as we go through the course of the year because of the nature of the data presented at the end of next year.

Got it thanks for taking the questions.

Thanks, Rob.

Okay.

Yes.

Operator, who is next.

I think our next question is from Bill with Jeremy Allen Your.

Your line maybe on mute.

Bill: Hi, this is Bill.

They'll go ahead with your question.

Hi, This is bill I'll monitor Oscar.

I just had a question about the auto eight program and some recent updates we saw over the summer we saw <unk> fast manufacturing update.

And we would assume that there is a preferable phenotype.

<unk> bag of cells as well along with their <unk>.

Results and we saw long term follow up with <unk>.

And I think there's about a 10% differential in response rates between those two we were wondering what you think is the appropriate bar for auto it and we're hoping you could comment on discrete contract differences between the three.

Contracts.

I'm on for Asthika.

So, first of all, your recollection is correct.

Well first of all bill Thanks for joining I think interesting set of questions.

Bill: We just had a question about the AutoAID program and, some recent updates we saw over the summer.

We saw a Gray Cells Fast Manufacturing update, and we assume that there's a preferable phenotype in their bag of cells as well, along with their results, and we saw a long-term follow-up with Cartitude, and I think there's about a 10% differential in response rates between those two.

Obviously, we do know, Florida from the Carty two trial that we do have a very significant level of activity, we're seeing with program.

I will say that we are getting longer kind of observation of which look very encouraging I think will be a big improvement for this patient group.

This is a program that includes two, targeting approaches, one against the BCMA, the other one against CD19. On the BCMA side, there's really the focus initially to test that novel highly potent BCMA car.

The design of that product in terms of the way that we find that the binding described to the CMA, our two binders single domain buyers.

Right.

I think we'll have to OCC, where some of the other programs are getting too I think it's still early days for some of those I think what we focused on the direct program is really to make sure. We do get this very high level of activity.

What we've done with this particular chromatic antigen receptor is really optimize it against multiple adenoma cells that carry very low levels of BCMA on the surface.

Again, these M&A spacing model hotels and in our case I would say optimized.

So, it's a highly potent approach, and we want to first see the impact of the BCMA car alone and then add on, as you pointed out, the CD19 car as we move forward.

I think making a prediction to kind of the type of data we're going to be able to see at the end of next year is probably a bit premature.

Very much on the buy rate sell off as well as in fact actually the actual construction of the car, which looks slightly different than that.

We're starting to treat patients or have initiated dosing patients now, and we'll have to see how the study progresses and how the data comes along.

But I think there should be a good chance for a very instructive and informative data set by the end of next year.

But, you know, it is a dose escalation study, and it is a very long study.

So, we'll have to see as we go through the course of the year kind of better feel for the nature of the data we'll be able to present at the end of next year.

More broadly used in the space is quite a bit of optimization that when they traded assets from a molecular perspective the product looks.

It looks different from that.

Allstate.

Our license J&J program at wholesale as far as the sales program.

But I think thats, probably what we do know at this point in time, and I think we need to see kind of how these programs shape up over time.

Sure.

I think at that point I think we'll have more information to share.

Okay.

Thank you.

Thanks, a lot.

Thanks, Bill next up is Gil Blum with Needham <unk> company.

Got it.

Standby.

We were wondering what you think is the appropriate bar for AutoAID, and we were hoping you could comment on discrete contract differences between the three contracts.

Thanks for taking the questions.

Thanks for taking our question.

Bill: Well, first of all, Bill, thanks for joining.

Thanks a lot.

Maybe a broader question first so given kind of the emerging data from five pacific's in B cell lymphoma.

Christian Itin: I think an interesting set of questions.

All right, who's next?

I think there's still a lot of onerous on developing novel T cell based therapeutics, particularly non Hodgkin lymphoma.

I think our next question is from Bill with Truist, and it looks like your line's open.

It's a really interesting question Gil.

I think our host may be on mute.

And I think what we do know I think we probably have the best data to sort of compare contrast activities and I'd problems, obviously, <unk>, where we do have pretty tight, though which is still the most active.

Obviously, we do know from the Cartitude trial that we do have a very significant level of activity we're seeing with programs, and obviously, they are getting longer-term observation, which looks very encouraging, and I think will be a big improvement for this patient group.

The design of that product, in terms of the way that it binds, that the binding is described to BCMA, are two binders, single-domain binders, that seem to be acting in conjunction and provide a very tight, very efficient binding to BCMA, which seems to be part of the mechanism that drives the high level of activity.

So that's kind of what certainly was known about that.

Bi specific T cell engagements that we have seen this.

Right and.

When we look at the activity between blood side, though and Ob sell there.

Significant levels of difference that we do pick up.

In that setting and enterprise services.

Daily comparable on the data set including the ability to provide long term.

Emissions, which is certainly what we sell data would suggest from the old car study.

Which is something that was not feasible or not that could help you demonstrated.

Tycho after the.

The module by specific.

<unk> data as our Bispecific for non Hodgkin's out they are interesting because in the savings from that they might be able to combine with some of the other antibody mediated.

Our antibody based modalities and Thats, certainly kind of where the big play that you see play out with a number of companies I think it is interesting to note that.

Roche decided to enter into a deal.

<unk>.

Actually with that profile.

Targets.

<unk>.

As well, so so clearly going into the <unk> space, which before the.

Primary focus of the company, while device specifics and they still felt that that's an area that we're going to get into which to me is certainly an interesting and suggests that as we have.

And this space is it looks like the level of activity described by the initial car T programs that came to market in <unk>. The activity of those present routes appears to be higher.

And potentially more sustained.

Compared to what we've seen to date on device specific well.

It's interesting, but it also seems to be emotion and it looks like some of the parties who have some very specific stakes into gang.

CTG consider it seems to go up.

Moving into into cell therapy.

I think we'll have to see where, you know, some of the other programs are getting to.

So, Bill, go ahead with your question.

I think it's still early days for some of those.

Hi, this is Bill.

I'm on for Ostica.

Okay. Thanks for that.

Considering we're expecting.

Quite a few updates across our team.

We just had a question about the AutoAID program and some recent updates we saw over the summer.

Platform in the second half should.

We saw a gray cells fast manufacturing update, and we assume that there's a preferable phenotype in their bag of cells as well, along with their results.

And we saw long-term follow-up with Cartitude.

Should we expect these presentations at ash or youre, not giving any guidance right now.

And I think there's about a 10 percent differential in response rates between those two.

We were wondering what you think is the appropriate bar for AutoAID, and we're hoping you could comment on discrete construct differences between the three constructs.

Well, first of all, Bill, thanks for joining.

I think an interesting set of questions.

Yes, I think for the most part I mean.

And then just to kind of the heap.

Statements of comprehensive <unk> got two time points typically in the year you got at the end of the year.

<unk> at the middle of the year that the European meeting.

And those are kind of the two primary events for data releases and certainly as we're looking for at the end of the year. The primary focus is going to be at ash.

Okay.

And on out of four.

How would you.

Describe the data the ballgame.

<unk> targeting car T when compared to data evolving from CB 708 targeting car Ts and the same indication.

I think what we focused on with our program is really to make sure we do get this very high, level of activity against BCMA-expressing multi-model cells, and in our case, obviously, optimized very much on the binder itself, as well as, in fact, actually the actual construct of the car, which looks slightly different than what is more broadly used in the space.

Obviously, we do know from the Cartitude trial that we do have a very significant level of activity we're seeing with the program.

I think we are.

With our own data is that we're able to induce complete remissions either.

A significantly elevated level the more patients that will be I think.

And obviously, now we're getting longer-term observation, which looks very encouraging, and I think will be a big improvement for this patient group.

The design of that product in terms of the way that the binding is described to DCMA, are two binders, single-domain binders, that seem to be acting in conjunction and provide a very tight, very efficient binding to DCMA, which seems to be part of the mechanism that drives the high level of activity, so that's kind of what's known about that.

I think precise Orion is obviously very encouraging that the first three patients dosed the highest dose level to achieve the metabolic CR.

We're still continuing observer observation of the patients that achieved a CR to understand for how long these deals can.

Can be maintained I think thats something we do not know yet at this point in time.

And I think the data is very encouraging because we seem to be getting to that level of CR without inducing significant level of toxicity, particularly with.

Inducing.

A major or having a major impact on the actual overall T cell compartment and deaths.

I would say alright, good position today.

And year to date. These patients so that looks really encouraging I think the date on CD 70 meters.

I don't think we know enough about it at this point in time to really get a good feel for that data.

But what.

What we do have with <unk> targeting is certainly a very unique way of targeting.

A very selective way of targeting T cells are being very focused on that population. So it.

But I think that's probably what we do know at this point in time, and I think we need to see kind of how these programs shape up over time, and, you know, I think at that point, I think we'll have more information to share.

I think we'll have to see where some of the other programs are getting to.

It will be interesting to see how some of these programs at both as a huge medical need.

Thank you.

I think it's still early days for some of those.

Thanks a lot.

I think what we focused on with our program is really to make sure we do get this very, high level of activity against DCMA-expressing multiple myeloma cells, and in our case, obviously optimized very much on the binder itself, as well as, in fact, actually the actual construct of the CAR, which looks slightly different than what is more broadly used in the space.

These patients need desperately additional treatment options.

Thanks, Bill.

There's quite a bit of optimization that went into it, and I think from a molecular perspective, the product looks different from, you know, obviously, the Allergen J&J program, and also as far as we know from the cells program, but I think that's probably what we do know at this point in time, and I think we need to see kind of how these programs shape up over time, and, you know, I think at that point, I think we'll have more information to share.

Thank you.

As they have a very I think.

Thanks a lot.

Okay.

The fact that clearly with the <unk> and we also expect EWC to providing and having two novel ways of actually going after this disease setting in a way that exactly as well as well tolerated.

Thanks, Bill.

Thank you.

Last one for Lucy.

Can you provide any information on potential cadence of Blackstone milestone.

Particularly given that youre going to have a pivotal readout in the fourth quarter and finally in 2023.

Operator: Next up is Gil Blum with Needham & Company.

Next up is Gil Blum with Needham & Company.

Yes.

I mean as you know we haven't.

Statistically broken out.

Stand by.

Doug milestone payments, but what we have said is that these are an ITT development and regulatory milestones.

Gil Blum: Thanks for taking our question.

Thanks for taking our question.

Read into that.

Gil Blum: Maybe a broader question first.

Maybe a broader question first.

Okay.

So, given kind of emerging data, from bi-specifics in the cell lymphoma, do you think there's, you know, still a lot of onus on developing novel T-cell-based therapeutics, particularly non-Hodgkin's lymphoma?

So, given kind of emerging data from bi-specifics in B-cell lymphoma, do you think there's, you know, still a lot of onus on developing novel T-cell-based therapeutics, particularly non-Hodgkin's lymphoma?

Okay very helpful. Thank you for taking our questions and congrats on the progress.

It's a really interesting question, Gil, and I think what we do know, I think where we probably, have the best data to sort of compare contrast activities and outcomes, obviously, is in ALL, where we're active, where we do have BlinCytl, which is still the most active bi-specific T-cell engager that we have seen as described.

And when we look at the activity between BlinCytl and Ovicell, there is a very significant level of difference that we do pick on in that setting, and it's sort of a highly comparable data set, including the ability to provide long-term remissions, which, you know, is certainly what the Ovicell data would suggest from the Olkarsh study, which is something that was, you know, not feasible or should not be demonstrated with BlinCytl as sort of the model bi-specific initial data.

Now, the bi-specifics in non-Hodgkin's, obviously, are interesting because in the sense from that they might be able to combine with some of the other antibody mediated.., are antibody-based modalities.

Thanks Bill.

And that certainly kind of was a big play that you've seen play out with a number of companies.

Thank you Jim next up is Kelly <unk> from Jefferies.

Sure.

The question is Paul.

Paul Pediatrics.

Could you share any color on the enrollment pace and is the focus only on quinoa you allocable patients.

Timeline youre targeting for the next phase of the study and also.

Curious which program.

Hawaii will be prioritized for internal pipeline development.

And the focus on commercialization of doubt.

Hum.

Combo ish may be expected for the next 15 years. Thank you.

I think it is interesting just to note that, you know, Roche decided to enter into a deal on cell therapy actually with a product that targets, CD20 and CD19 as well.

It's a really interesting question, Gil, and I think what we do know, I think where we, probably have the best data to sort of compare, contrast activities and outcomes, obviously, is in ALL where we're active, or we do have BlinCyto, which is still the most active bi-specific T-cell engager that we have seen on this slide, and when we look at the activity between BlinCyto and Ovicell, there is a very significant level of difference that we do pick up in that setting, and it's sort of a highly comparable data set, including the ability to provide long-term remissions, which, you know, is certainly what the Ovicell data would suggest from the Olkarsch study, and which is something that was, you know, not feasible or should not be demonstrated with BlinCyto as sort of the model bi-specific and the initial data.

Yes, Thanks, Kelly really good question so.

With regards to the patient population would be targeting in pediatric AML.

So clearly going into the BNHL space, which before, you know, the primary focus of the company wasn't biospecifics, and they still felt that that's an area they wanted to get into, which to me certainly is interesting and suggests that as we had, you know, seen in the space, it looks like the level of activity described by the initial CAR-T programs that came to market in the OVCL, the activity of those programs appears to be higher and potentially more sustained compared to what we've seen to date on the biospecifics realm.

So I think it's interesting, but it also seems to be emotion, and it looks like, some of the parties who have some very specific stakes in the game seem to reconsider and seem to broaden out, including moving into cell therapy.

Obviously for the initial patients where we're going for.

Kate Spade had basically no options left to be to have access to.

Therapy.

And that is certainly there.

Thanks for the study and also I'm curious which program.

Hawaii will be prioritized for internal pipeline development.

And then the focus on commercialization of doubt.

Wow.

Travel issue to be expected for the next two years. Thank you.

Yeah. Thanks got a really good question so with regards to the.

Now, the bi-specifics in the Hodgkin's, obviously, are interesting because it depends from, that they might be able to combine with some of the other antibody-mediated or antibody-based modalities, and that certainly kind of was a big play that you've seen play out with a number of companies.

I think it is interesting just to note that, you know, Roche decided to enter into a deal on cell therapy actually with a product that targets CD20 and CD19 as well, so clearly going into the BNHL space, which before, you know, the primary focus of the company wasn't bi-specifics, and they still felt that that's an area they wanted to get into, which to me certainly is interesting and suggests that, as we have, you know, seen in the space, it looks like the level of activity described by the initial CAR-T programs that came to market in the OBCL, the activity of those programs appears to be higher and potentially more sustained compared to what we've seen to date on the bi-specific problem.

The patient population, we've been targeting in pediatric AML.

Obviously for the initial patients where we're going for.

Thank you for that.

In our case, they've had basically no option left to be have access to.

With therapy.

Considering we're expecting quite a few updates across our HEIM, platform in the second half, should we expect these presentations with ASH, or you're not giving guidance right now?

And that is certainly the case with children, who are sort of past beyond <unk> and what we could demonstrate is obviously a very high level of activity good safety and with that I think.

Gil Blum: Yeah, I think for the most part, I mean, if you look into kind of the HEIM, you know, segment of conferences, you know, you've got two time points typically in the year.

Sort of established kind of the basic profile of the product.

As we go forward I think there's the opportunity to also enrolled patients.

We'll be <unk> eligible I think that becomes a possibility as we start to move forward.

The key activities that we're engaged in that program is also too.

Do some modifications on the manufacturing process as well and kind of actually.

We'll explore that.

<unk> group with additional patients.

I think that dataset will then actually through that formed the basis for any decision.

Moving the program forward, so we expect that data to become available.

You've got at the end of the year, you've got the ASH meeting at the middle of the year, you've got the European meeting, the EHA meeting, and those are kind of the two primary events for data releases, and certainly as we're looking through the end of the year, the primary focus is going to be on ASH.

This initial cohort.

During.

Probably the middle of next year and that also then actually gives us the basis for moving the program forward in terms of prioritization.

You are correct, we have obviously quite a set of interesting opportunities for building too.

The key focus is going to be on delivering a reselling adobe sell through market, that's clearly where the primary focus of the organization is.

But there will be opportunities as we go through the course of next year to actually.

Looked at advancing some of the earlier program.

Gil Blum: And on Auto IV, how would you describe the data that's evolving for TRBC targeting CAR-T, when, say, compared to data evolving from CD70 targeting CAR-Ts in the same indication?

<unk> <unk> 42, as what was over four which I think both of them will start reaching.

Christian Itin: I think what we're seeing with our own data is that we're able to induce complete remissions, at a pretty, you know, significant or elevated level for patients to sort of be, you know, I think, I think precise around it.

Interesting data points.

During the course of next year.

We'll be comp programs.

Have you fully developed at that point in time.

Thank you very much thanks.

Thanks, Kevin.

Okay.

Alright next step we have.

Chuan Hong from J P. Morgan.

Sam.

This is Sean.

Hi, This is Sean on for Eric Joseph Thanks for taking our question. So just a follow up on the auto floor.

Program. So I would think the updates on <unk> are there any new.

Interpretation of the lack of our go forward expansion into Porfirio until you.

You expect the product made from the modified manufacturing process to have that impact.

<unk> parallel.

Expansion potential.

So yes, that's it thanks.

Okay. Thanks, good question.

So what we did see obviously with <unk>, we did see the clinical responses that we also.

Let's see.

Nicely expand.

Car T cells in the actual.

Tumor lesions.

That's data that we shared at the conference. We did not have not see is elevated levels of car T cells in the periphery, obviously, we can techniques.

The car T cells, but we don't see significant elevated levels.

This is not uncommon if you have also depending on booking.

<unk> patients as an example that you could also have patients that actually do show.

Complete remissions without actually showing any significant increase in level of car T cells.

What we're expecting to do with the.

The changes in the manufacturing process is really to help us.

In this patient pool, which obviously.

Has what are we collecting patient sales felt the patient that could also potentially include.

Lymphoma cells. The first step in the manufacturing processes do you actually have to get removed.

It could also include lymphoma ourselves.

The case, where we're moving <unk> onto.

So if we start actually with a reduction of sales in the first step in that regard to the manufacturing process.

This is somewhat different than what you normally use what we can do is adjust the process such that we can actually volumes are in the process.

In a short period of time and that May actually have an impact on some of the sell through data.

As we've seen in some of the other programs as well.

Whether that ultimately will show a difference in terms of.

The T cells, we see in vivo formed in these patients. So I think that remains to be seen. This is frankly, an experiment that actually had some developments there.

There is no greater presence.

Sales on here.

But it will be interesting to look at that then I'll segue to tell me, we're going to do that.

That's very helpful. Thanks.

Thanks, Sean.

Alright.

Very much I'd like to turn it back to Olivier for closing remarks.

Obviously, very encouraging that the first three patients, those at the highest dose level, achieve the metabolic CR.

So, that looks really encouraging.

So I think it's interesting, but it also seems to be emotion, and it looks like some of the parties who have some very specific stakes in the game seem to reconsider and seem to broaden out, including moving into Thank you for that.

I think we're still continuing observation of the patients that have achieved the CR to understand for how long these CRs can be maintained.

I think the data on CD70, which is, you know, I don't think we know enough about it at this point in time to really get a good feel for that data.

I think that's something we do not know yet at this point in time. And I think the data is very encouraging because we seem to be getting to that level of CR, without inducing any significant level of toxicity, particularly without inducing a major, or having a major impact on the actual overall B cell compartment, and thus, obviously, are in a good position to maintain immunity in these patients.

But, you know, what we do have with TRBC1 targeting is certainly a very unique way of targeting, and a very selective way of targeting T cells and being very focused on that population.

Considering we're expecting quite a few updates across your HIEM platform, in the second half, should we expect these presentations of ASH or you're not giving guidance right now?

Alright. So this is Christian.

So, it'll be interesting to see how some of these programs evolve.

Yeah, I think for the most part, I mean, if you look into kind of the HIEM segment of conferences, you know, you got two time points typically in the year.

There's a huge medical need.

You got at the end of the year, you got the ASH meeting, at the middle of the year, you got the European meeting, the EHA meeting.

Like to thank everyone for joining.

You know, these patients need desperately additional treatment options, and they're very, I think, I'm excited about the fact that clearly with the TRBC1 and we also expect TRBC2 providing, and having two novel ways of actually going after this disease setting in a way that is actually as well as well tolerated.

And those are kind of the two primary events for data releases.

And certainly as we're looking towards the end of the year, the primary focus is going to be on ASH.

For him to take the time for today's update and we're looking forward to keeping you posted Meanwhile, and CEO probably back in September numbers have Meanwhile, for those of you can get away I wish you a great summer break.

And on Auto IV, how would you describe the data that's evolving for TRBC targeting, CAR-T when they compare it to data evolving from CD70 targeting CAR-Ts in the same indication?

I think what we're seeing with our own data is that we're able to induce complete permissions, at a pretty, you know, significant or elevated level for patients to sort of be, you know, I think precise around it.

Obviously, very encouraging that the first three patients, the highest dose level to achieve the metabolic CR.

I think we're still continuing observation of the patients that have achieved the CR to understand for how long these CRs can be maintained.

I think that's something we do not know yet at this point in time. And I think the data is very encouraging because we seem to be getting to that level of CR, without inducing any significant level of toxicity, particularly without inducing a major or having a major impact on the actual overall B cell compartment and thus, obviously, are in a good position to maintain immunity in these patients.

Thank you.

So, that looks really encouraging.

Gil Blum: And a last one for Lucy, can you provide any information on potential cadence of Blackstone, milestone, particularly given that you're going to have a pivotal readout in the fourth quarter and a filing in 2023?

I think the data on CD70, which is, you know, I don't think we know enough about it at this point in time to really get a good feel for that data.

Lucinda Crabtree: Yeah, thanks Gil.

But, you know, what we do have with TRBC1 targeting is certainly a very unique way of targeting and a very selective way of targeting T cells and being very focused on that population.

And I mean, as you know, we haven't specifically broken out those milestone payments, but what, we have said is that these are related to development and regulatory milestones.

So, it'll be interesting to see how some of these programs evolve.

So, I mean, you know, read into that as you will, Gil.

There's a huge medical need.

Okay.

You know, these patients need desperately additional treatment options.

Very helpful.

And we're very, I think, excited about the fact that clearly with the TRBC1 and we also expect, TRBC2 providing and having two novel ways of actually going after this disease setting in a way that is actually as well as well tolerated.

Get some rest and we're looking forward to seeing you and keep you updated on what's going to be an exciting second half of the year for us. Thank you.

Q2 2022 Autolus Therapeutics PLC Earnings Call

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