Q3 2021 Autolus Therapeutics PLC Earnings Call

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

Hello, ladies and gentlemen, and welcome to the <unk> Therapeutics third quarter 2021 financial results Conference call.

As a reminder, this conference call is being recorded.

I would now like to turn the conference over to your host Dr. Lucinda Crabtree Vice President business strategy. Please go ahead.

Lucinda Crabtree: Thank you, Daniel. Good morning or good afternoon, everyone, and thank you for joining us to take part in today's call on the financial results and operational highlights for the third quarter of 2021. I am Lucinda Crabtree, Vice President of Business Planning and Strategy. With me today are Dr. Christian Iton, our chief executive officer, Christopher Van, our chief operating officer, and Andrew Oakley, our chief financial officer.

Thank you Daniel good morning, or good afternoon, everyone and thank you for joining us to take part in today's call on the financial results and operational highlights for the third quarter 2021.

I am Lucinda Crabtree Vice President.

Hunting and strategy.

With me today are Doug.

Christian item, our Chief Executive Officer, Christopher <unk>, our Chief operating Officer, and Andrew Oakley, Our Chief Financial Officer.

Lucinda Crabtree: Before we begin, I would like to remind you that during today's call, our discussion will contain forward-looking statements. All statements other than statements of historical facts on this call are forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the section titled Risk Factors in our annual report on Form 20F filed with the Securities and Exchange Commission on March 4th, 2021, which can be accessed on the Edgar database at www.s.c.gov, and in subsequent filings we make with the SEC from time to time.

Before we begin I would like to remind you that during today's call. Our discussion will contain forward looking statements.

Statements other than statements of historical facts on this call are forward looking statements.

Actual results may differ materially from those indicated by these forward looking statements as a result of various important factors, including those discussed in section titled Risk factors in our annual report on form 20-F filed with Securities and Exchange Commission on March four 2021, which can be accessed on the Edgar database at www.

SEC don't golf and in subsequent filings, we make with the SEC from time to time.

Lucinda Crabtree: The forward-looking statements on this call reflect the company's views as of today, November 3, 2021, regarding future events and should not be relied upon as representing the speakers or the company's views as of any subsequent date. While the company may elect to update these forward-looking statements at some future point, it specifically disclaims any obligations to do so, even if the company's views change. These forward-looking statements should not be relied upon as representing the company's views as of any subsequent date other than today.

The forward looking statements on this call reflect the company's views as of today November <unk> 2021 regarding future events and should not be relied upon as representing the speakers' or the company's views as of any subsequent date.

While the company may elect to update these forward looking statements at some future point the company specifically disclaims any obligations to do so even if the company's views change.

These forward looking statements should not be relied upon as representing the company views as of any subsequent date to today. Please.

Lucinda Crabtree: Please be advised that today's call is being recorded and webcast. So on slide three, you will see the agenda for today, and it is as follows. Christopher will provide an overview of our operational results for the third quarter of 2021. Andrew will then discuss the company's financial results before Christopher will conclude with upcoming milestones and any other concluding comments. Finally, we will, of course, welcome your questions following our remarks.

Please be advised that today's call is being recorded and webcast.

So on slide three you will see the agenda for today and in cases falling Christopher will provide an overview of our operational results since third quarter of 2021.

Andrew will then discuss the company's financial results.

Christian will complete without coming milestones and any other completing comments.

Finally, we will of course welcome your questions following our remarks tenths Christmas.

Christopher Vann: Thank you, Sinda, and good morning to you all. Thank you for joining us. It's my pleasure to review our operating progress for the third quarter of 2021. Now, if we move to slide five, I'd like to give a quick update on the key pipeline activity. And first of all, a multi-center Felix study for our lead program, OberSEL, which is progressing very well. Enrollment in the phase two portion of the study is on track, and consequently, we are reiterating our guidance that the primary endpoint data will be delivered in the middle of next year, with the full pivotal data available by the end of 2022.

And good morning to you all.

Thank you for joining us it's my pleasure to review our operating progress for the third quarter 2021.

If we move to slide five I'd like to give a quick update on the key pipeline activities.

And first of all our multicenter Phoenix study for our lead program <unk>, which is progressing very well.

Enrollment in the phase II portion of the study is on track and consequently, we are reiterating our guidance. The primary endpoint data will be delivered in the middle of next year.

With the full pivotal data available by the end of 2022.

Furthermore, we are pleased to be in a position to update you.

The initial observations from the 16 patients in the phase one be running portion of this multicenter Felix study.

Christopher Vann: Furthermore, we are pleased to be in the position to update you that the initial observations from the 16 patients in the Phase 1B running portion of this multi-centrophelic study, where we observed the one month complete response rate and safety data, are so far consistent with the data reported from the academic all-cast study of Overcell in relapse refractory adult acute lymphoblastic leukemia. Clearly, this is very encouraging, and we plan to present this early data from the Phase 1B cohort later this year at Ash.

<unk>.

When we observe the warm month complete response rate and safety data.

Ah so far consistent with the data reported from the academic school cost study of oversell and relapsed refractory.

Adult acute lymphoblastic leukemia.

Clearly this is very encouraging.

And we plan to present this early data from the phase <unk> cohort later this year ash.

In addition, we also expect to update you at Ash on additional data from the old car 19 extension study of <unk> and indolent B cell non Hodgkin's lymphoma indications as well as the first.

Christopher Vann: In addition, we also expect to update you at Ash on additional data from the Allcar 19 extension study of OberCell in Indolent B-Sel non-hococans lymphoma indications, as well as the first early clinical data from the Carpell extension study, which is evaluating our next generation product, Auto 122, in pediatric air allowance. In addition to the over-cell news flow, we also plan to provide an update on our phase one trial of Auto4 in peripheral T-cell infomer in the first half of 2022. If we move to slide six, we'd like to walk you through general corporate updates from the third quarter. Firstly, during this period, we were delighted to announce the appointment of John H. Johnson as non-executive chairman.

Clinical data from the comp how expansion study.

Which is which is evaluating our next generation product ultra 122 in pediatric allo.

In addition to the Oversell news flow. We also plan to provide an update on our phase one trial of OTO four in peripheral T cell lymphoma in the first half of 2022.

If we move to slide six.

Like to walk you through a general corporate updates from the third quarter.

Firstly during this period, we were delighted to announce the appointment of John Page Johnson as Nonexecutive Chairman.

John brings a wealth of commercial oncology business experienced the order list and is a recognized leader in the biopharmaceutical industry, having held a number of executive operational and commercial leadership roles.

His experience will clearly be invaluable as we look towards the.

The commercial launch of episodes.

We're also very pleased to announce in September planning approval was granted to build the company's new manufacturing facility in Stevenage U K.

Christopher Vann: John brings a wealth of commercial oncology and business experience to Autlus and is a recognized leader in the biopharmaceutical industry, having held a number of executive, operational, and commercial leadership roles. His experience will clearly be invaluable as we look ahead because I'm not sure how long. We're also very pleased to announce that in September, planning approval was granted to build the company's new manufacturing facility in Stevenage, UK. This 70,000 square foot facility will be leased to Autolus and is another important step for Autlis on our journey to becoming a fully integrated commercial company.

The 70000 square foot facility will be leased thoughtless and there is another important step forward for us on that journey to becoming a fully integrated commercial company.

We anticipate that this will meet the global demand for initial indications for <unk>.

And Thats, what will be though for capacity of approximately 2000 GMP batches of year. It will also have a further scope to expand beyond that if needed.

In terms of other updates we promoted Chris Williams Senior Vice President of corporate development.

Erik Swan to senior Vice President of human resources.

Following the departure from the pass holder, our Chief business Officer, and we're extremely grateful to the SaaS with services total us and wish him all the best for the future.

We are delighted to welcome Chris and I will like to the senior leadership team.

As announced as part of the Q2 earnings as post period events.

Christopher Vann: We anticipate that this will meet the global demand for initial indications for Oversell, and as it will be handled at a capacity of approximately 2,000 GMP batches a year, it will also have a further scope to expand beyond that if needed. In terms of other updates, we promoted Chris Williams to Senior Vice President of Corporate Development, and Alec Swan to Senior Vice President of Human Research. This follows a departure from Mateus Holder, our chief business officer, and we're extremely grateful to Mattias for his service to totalists and wish him all of the best for the future. We are delighted to welcome Chris and Alec to the senior leadership.

We were very pleased to also announced the appointment of talk talk to Edgar Brenda who has.

Now joined US as our new Chief Development Officer company as well as Wolfram Kruger, who joined us as the new head of clinical development.

Finally, we announced an option and license agreement with Madonna.

We granted an.

An exclusive license to develop and commercialize mrna therapeutics incorporating spotless is for proxy bond is for up to four immuno oncology targets.

This is further tangible recognition of the technology base that we have developed within the company.

With that let's move onto the next slide slide seven.

What we'd like to do is to provide a brief overview with regards to <unk>, which is on track to be the first product.

Commercially launched by all of Us.

As you remember our focus of the company is on delivering the Phoenix study in adult patients with relapsed refractory AML.

Christopher Vann: As announced as part of the Q2 earnings as post-period events, we were very pleased to also announce the appointment of Dr. Edgar Brendel, who has now joined us as the new Chief Development Officer of the company, as well as Wolfram Brugger, who joined us as the new head of clinical development. Finally, we announced an option and license agreement with Moderna, where we granted Moderna an exclusive license to develop and commercialize MRNA therapeutics incorporating Oralysis proprietary binders for up to four immunoncology targets. This is further tangible recognition of the technology base that we have developed within the company.

With the study enrolling patients who have both postpaid and the tumor map in the industry.

As well as patients just progressing in the relapse setting, but has not or may not have yet received and achieves a matrix implant in the treatment model.

As we mentioned earlier, we're also exploring the activity of oversell beyond their low in the context of the old car 19 extension study and we expect to provide further updates in Q4 2021 to the data already released the IHA in June of this year.

In addition to the updates in Follicular lymphoma mantle cell patients. We will also include data on patients with DLP CFO and CLO.

In addition, we are also now treating patients pediatric patients with <unk> 122, which is a newer product that builds upon the <unk> backbone by adding a novel CD 22 androgen receptor.

Christopher Vann: With that, let's move on to slide seven. What we'd like to do is to provide a brief overview with regard to OberSEL, which is on track to be the first product commercially launched by Autos. As you recall, our focus for the company is on delivering the Felix study in adult patients with relapse-refractory ALL, with the study enrolling patients for both post-blenotumumab and Inotuselamab, as well as patients that are just progressing in the relapse setting that have not, or may not have yet received Inotusimab and Blenotumab.

As mentioned previously we also expect to share some of the initial clinical data on this product also in Q4 2021.

Next slide please slide eight.

Focusing specifically on adult acute lymphoblastic leukemia, it's worth remembering what are the key features of a successful cell therapy for this indication.

<unk> was specifically designed to tackle the underlying biology of auto Alo and Thats why we believe it's uniquely placed to address the current limitations of therapy in this indication.

One of the core challenges with this disease.

Proliferating disease being stem cell like in nature.

And another challenge.

Christopher Vann: As we mentioned earlier, we're also exploring the activity of Obercel beyond ALL in the context of the All-Car-19 extension study, and we expect to provide further updates in Q4 2021, to the data already released at EHA in June of this year. In addition to the updates on follicular lymphoma and mantle cell patients, we'll also include data on patients with DLVCL and CLO.

Patients often present in very cold condition.

The fast off rate bond of Overset, whereby the cell interacts with its target releases more quickly means that the sales experience less exhaustion, and hence better investment and perception systems.

Then at the same time.

Because it's a quicker more efficient interaction with the target. We would also expect to see less inflammation and lower levels of toxicity.

Let's move to slide nine.

Let me remind you that still remains a very high unmet medical need for adults Ll was approximately 8400, new cases diagnosed yearly worldwide in the last line setting.

Christopher Vann: In addition, we're also now treating pediatric patients with Auto 122, which is a newer product that builds upon the overcell backbone by adding a novel CD22 antigen receptor. As mentioned previously, we also expect to share some of the initial clinical data on this product also in Q4, 2021.

Approximately 3000 of these cases resides in the U S and EU.

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

About 30%, 40% will achieve long term remission.

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

The approved products include.

Within the tumor mass and then choose the Memphis indication and in some countries Carter's is in process of being launched.

Christopher Vann: For foccysmocysicolemia, it's worth remembering what the key features of a successful car cell therapy for this indication are. Bovisel was specifically designed to tackle the underlying biology of Adol-A-L, and that's why we believe it's uniquely placed to address the current limitations of therapy in this indication. One of the core challenges with this disease is that it's a fast proliferating disease being stem-like in nature. And another challenge is that patients often present in very cold conditions.

We believe however, there remains a real opportunity for a product candidate with <unk> profile in this setting and to remind you all this.

<unk> has been granted orphan drug designation by the FDA for ALLL Prime designation by EMA and ILEC designation by NHRA.

Moving on to slide 10.

So, let's just take a moment to recap on the data presented to date.

Key new data were recently presented at EAA for the Orca study, notably an update on durability of response as measured by event free survival.

As we've already communicated and as you would expect to the car T cell product in this indication <unk> has high levels of initial response.

However, as the patients go out post treatment, what we're seeing now is the event free survival is maintained in the Kaplan Meier curve with it stabilize over time.

Christopher Vann: The fast off rate binder of overcell, whereby the cell interacts with its target and releases more quickly, means that the cells experience less exhaustion and hence better integration and persistency. Then, at the same time, because of the quicker and more efficient interaction with the target, we would also expect to see less inflammation and lower levels of toxicity. Please move to slide 9. Let me remind you, there still remains a very high unmet medical need for adult ALL with approximately 8,400 new cases diagnosed yearly worldwide in the last line set. Approximately 3,000 of these cases reside in the US and EU.

This emerging evidence gives us a level of confidence to oversell has the potential to.

A good proportion of these patients into long term remission.

So turning to slide 11 to our knowledge. This is the first time that such a plateau of long term response has been seen in this disease setting.

Furthermore, it provides a degree of validation for the basic design premise of Oversell subsist long response is correlated with exceptional persistence that we're seeing with the product.

Not only do we see about 10 fold increase in the maximum number of car T cells that have been reported in other programs, but the level of car T cells is maintained over time.

It's our belief that persistence is actually a prerequisite to be able to translate our molecular response into a long term remission in this indication and the emerging data seems to support this.

Christopher Vann: Whilst combination chemotherapy enables 90% of adult ALL patients to achieve CRs, only about 30 to 40% will achieve longer-term remission once relapsed; patients have a median overall survival of less than a year. The approved products include in the tumor man and in a Tuesday map for this indication, and in some countries, Carta is in the process of being launched. We believe, however, there remains a real opportunity for a product candidate with Obersell's profile in this setting, and to remind you all, Obisell has been granted orphan drug designation by the FDA for ALL, prime designation by EMA, and ILAP designation by MHRA. Moving on to slide 10.

On the right hand side of the slide you'll also see the adverse event profile and as reported previously we havent seen high grade cytokine release syndrome.

Furthermore, this was achieved without perspective intervention and with only limited use of supportive care, such as Tuscaloosa map and steroids.

And those vasopressor use in these patients.

So again as would be anticipated based upon the design hypothesis for the product oversell. It has a very good safety profile, which should render the product more easily manageable in the clinic.

In conclusion, the data is very encouraging with Airbus, So having a potentially unique efficacy and safety profile in this clinical setting.

So moving on to slide 12.

To put this data into context with the data published for the other products used in this space I'd like to first compare it to the existing standard of care and the data sets. The foundation for the approvals approvals tumor map of entities.

Christopher Vann: So let's just take a moment to recap on the data presented today. Key new data were recently presented at EHA for the Orcast study, notably an update on durability of response as measured by event-free survival. As we've already communicated, and as you would expect the McCarthy cell product in this indication, Oversel has high levels of initial response. However, as the patients go out post-treatment, what we're seeing now is that event-free survival is maintained on the Kaplan-Mya curve, with it stabilizing over time.

Overall as you can see the available data for <unk>, thus far stacks up very well against both of these programs, particularly in respect of offering potential for high levels of activity.

A more sustained response.

Turning to slide 13 to cost US was recently approved in adult patients with relapsed refractory <unk>.

The data supporting this approval shows a 24%.

High grade Crs.

Neurotoxicity of 87%.

In patients experiencing any grade neurotoxicity in the label.

Christopher Vann: This emerging evidence gives us a level of confidence that Oversell has the potential to get a good proportion of these patients into long-term remission. So, turning to slide 11, to our knowledge, this is the first time that such a plateau of long-term response has been seen in this disease setting. Furthermore, it provides a degree of validation for the basic design premise of OberSel since this long response is correlated with the exceptional persistence that we're seeing with the product. Not only do we see about a tenfold increase in the maximum number of CART cells that have been reported in other programs, but the level of CART cells is maintained over time.

And on the efficacy side I would like to point you to oversell complete response rate and compare it with the excellent persistence and <unk>.

Free survival observed annual cost study.

In conclusion taken in context, we believe all cost 19 data is very encouraging with oversell, having a potentially unique efficacy and safety profile in this clinical setting.

And we feel we have a very nicely differentiate product for this high medical need patient population based on both durability of response and overall safety profile.

Slide 14 please.

Moving onto the <unk> registration study Felix this is 100 patient study in relapsed refractory adult AML patients. It has two subpopulations.

Christopher Vann: And it's our belief that persistence is actually a prerequisite to be able to translate a molecular response into a long-term remission in this indication, and the emerging data seems to support this. On the right-hand side of the slide, you'll also see the adverse event profile, and as reported previously, we haven't seen high-grade phyto-crine release syndrome. Furthermore, this was achieved without prospective intervention and with only limited use of supportive care, such as Tosoluzumab and steroids, and no vasopresser use in these patients.

Relapsed refractory post expose patients to planar and interchange format as well as patients.

Hearings with regards to previously receiving blinatumomab or in the Tucson lab.

The primary endpoint.

The study is complete response rate and the secondary endpoints include molecular responses.

As well as event free survival and duration of response.

So let us turn to the market size.

On the current market size and slide 15. Please.

Okay.

I touched upon the opportunity and Alo and an earlier slide in terms of patients, but what I'd like to just highlight is the sales performance of the current standard of care.

Christopher Vann: So again, as would be anticipated based upon the design hypothesis for the product, Oversell has a very good safety profile, which should render the product more easily manageable in the clinic. In conclusion, the data is very encouraging, with Obosel having a potentially unique efficacy and safety profile in this clinical setting. Moving on to slide 12, to put this data into context with the data published for the other products used in the space, I'd first like to compare it to the existing standard of care and the data sets that were the foundation for the approvals of Blenotumumab and Inotumab. Overall, as you can see, the available data for Obercel thus far stacks up very well against both of these programs, particularly in respect of offering potential for high levels of activity with a more sustained response.

Glen site was known as Glen the tumor mass.

Amgen reported yesterday sales growth of 40% in the third quarter 30, sorry, 40% growth in the third quarter on a year by year basis, as composed as compared to third quarter last year.

As you can see if.

If we look at the first half sales in 2021, and 'twenty, sorry, 2020 in 2021 with sales of $187 million and.

$250 million, we have a growth in the region of around 20%.

Yeah.

If we apply publicly available information on the proportion of use in pediatric and adult patients and by using a very simple extrapolation that patients typically receive on average about two cycles of this product.

This provides further evidence.

And translates to approximately 2000 patients currently receiving this commercial product globally in 2021.

Amgen have stated that one of the underlying key drivers for sales increase has been the expansion to the community Hospital segment in the U S beyond the academic transplant centers.

Christopher Vann: Turning to slide 13, Takartis was recently approved in adult patients with relapse refractory airlin. The data supporting this approval shows a 24% high-grade CRS and neurotoxicity of 87% in patients experiencing any grade neurotoxicity in the label.

Well Blaine.

<unk> is moving to non academic centers. We also expect the launch of P&C.

<unk> also established car T experience in those centers.

Both of these developments bode well for our product with the properties of oversell.

Slide 16 please.

Slide 16 summarizes the current situations so.

Christopher Vann: And on the efficacy side, I would like to point you to Oversell's complete response rate and compare it with the excellent assistance and event-free survival observed in your customer. In conclusion, taken in context, we believe all CAR-19 data is very encouraging, with Overcell having a potentially unique efficacy and safety profile in this clinical setting. And we feel we have a very nicely differentiated product for this high-medical need patient population based on both durability of response and overall safety process. Slide 14.

Hello.

From the all car 19 study, we have observed a subset of patients with a high level of sustained CR achieved without subsequent stem cell transplant.

Durability of remissions that are highly encouraging with 50%.

DSS at 12 and 24 months.

<unk> is well tolerated despite being used in a heavily pre treated patient pool with high disease burden.

We observed no grade three or higher Crs.

And in the 20% patients experiencing any great items. These results swiftly.

Christopher Vann: Moving on to the Obercell registration study, Felix, this is a 100 patient study in relapse-refractory adult ALL patients, has two subpopulations: Relapse-Refractory Post-Exposed Patients to Blinna and Inotuselam as well as patients in experience with regard to previously receiving Blenotumab or Inotuselamab. The primary endpoint of the study is complete response rate, and the secondary So let us turn to the market size and the current market size on slide 15.

Overall, we're very excited about the opportunity for <unk> and a sizable market with clear unmet medical need.

Now taking a different tack that moving on to other indications. Please move on to slide 12.

At <unk> in June, which had data from the old car extension phase.

In this call and for all of the nine patients with dose achieved at <unk>.

Metabolic complete response.

Yes.

And in this small population the safety profile was consistent with that observed in our rollout with no patients experiencing high grade Crs.

Furthermore, none of the patients experienced any form of neurotoxicity.

One of the patients Unfortunately contracted Covid and died as a consequence of Covid related aes.

The patient however, incomplete metabolic <unk>.

Permission.

There was one further patient who developed single lesion in this game, which could be removed surgically, but obviously that event was also considered the progression.

Christopher Vann: I touched upon the opportunity in ALL in an earlier slide in terms of patients, but what I'd like to just highlight is the self-performance of the current standard of care. Blin Saito is always known as Glen the tumor man.

No other patients progressed on all of our patients in remission.

Moving on to slide 18.

Given <unk> mechanism of action profile. We're also evaluating this use its use in other b cell malignancies.

Christopher Vann: Amgen reported yesterday sales growth of 40% in the third quarter, sorry, 40% growth in the third quarter on a year by year basis as compared to the third quarter last year. As you can see, If we look at the first house sales in 2020 and 2021, there will be sales of 187 million and 250 million with a growth in the region of around 20%. If we apply publicly available information on the proportion of use in pediatric and adult patients and by using a very simple extrapolation that patients typically receive, on average, about two cycles of this product, this provides further evidence and translates to approximately 2,000 patients currently receiving this commercial product globally in 2021.

Non hodgkin's lymphoma patients as well as CFO patients are being evaluated as part of the extension of Neocon 19 study.

We're also conducting in collaboration with our academic partners at UCL in the Carousel study.

They use in primary CNS lymphoma, and aggressive lymphoma, similar to Dod ECL is exclusively localized.

In the brain.

In addition, as already mentioned, we are conducting an extension of the top health study with water 122 in pediatric patients.

These programs taken together will give us a very good overview of the activity of <unk> across the spectrum of CD 19 positive malignancies.

Moving on on.

On slide 19.

A brief reminder of the broad and exciting technology toolkit that we have developed an all to us, particularly as it relates to this suite of next generation programs.

Some of which you will recall, we showcased at ACR last year.

Christopher Vann: Andrew has stated that one of the underlying key drivers for sales increase has been the expansion to the community hospital segment in the US beyond academic transplant centers. While Blencerta in ALL is moving to non-academic centers, we also expect the launch of Brianzi in DLBCL to also establish CART experience in those centers. Both of these developments bode well for a product with these properties.

We're looking to move these programs forward into the clinic through 2021 and into 2022, including in our first solid achievement programs.

Yes.

It's worth also reiterating the deal we recently signed with Madonna, which highlight the highly skilled in house bonded discovery team, we have here in Auckland and the applicability of our work to other potential modalities.

Finally on slide 20.

You can see that we have tabulated. These next generation programs alongside the expected phase one start dates.

You will note as discussed we started the pediatric allo clinical trial of water 122 in Q4 of 2020.

Christopher Vann: Slide 16, please. Slide 16 summarizes the current situation for Oversell in ALL. From the Orkar-19 study, we have observed a subset of patients with a high level of sustained CR achieved without subsequent stem cell transplant, and durability of remissions that are highly encouraging with 50% EFS at 12 and 24 months. Overcell is well tolerated despite being used in a heavily pre-treated patient pull with high disease burden.

We also expect the auto six Mg study in <unk> positive solid achievements to start enrolling.

First half of 2022 quarter four is also likely to move into the clinic in first half 2022, and finally also eight next generation multiple myeloma product will move into the clinic in Q4 2021.

That.

Let's turn over to slide 21 in.

Turn over the call to Andrew Thank you.

Thanks, Chris and good morning, or good afternoon to everyone. If we can move to slide 22.

My pleasure to review our financial results for the third quarter of 2021.

So if we start with <unk>.

Cash position our cash at the end of September totaled 173 point.

Christopher Vann: We observe no grade three or higher CRS, and in the 20% patients experiencing any grade ICANs, these results swiftly. Overall, we're very excited about the opportunity for oversell in a sizable market with clear unmet medical needs. Now taking a different track of moving on to other indications, please move on to slide 12. At EHA in June, we shared data from the all-car extension phase. In this lymphopoietin, all of the nine patients that were dosed achieved a metabolic complete response, and in this small population, the safety profile was consistent with that observed in ALL, with no patients experiencing high-grade CRF. Furthermore, none of the patients experienced any form of neurotoxicity. Unfortunately, one of the patients died as the consequence of COVID-related AEs. The patient, however, died in complete metabolic remission.

$1 million and that compares to $216 4 million that we had at the end of June.

I will note. However that this figure does not include an R&D tax credit that we received in October of this year.

Churn of approximately $25 million.

Net total operating expenses for the three months ending 30 September.

2021, $44 million and Thats net of grant income of <unk> 2 million and this compares with net operating expenses at $42 $7 million.

Grant income of <unk> 4 million for the same period in 2020.

Research and development expenses decreased to $32 3 million for three months ended 30 September 2021 from 33 5 million for the three months ending 30 September 2020, cash costs, which exclude depreciation and amortization as well as share based.

<unk> decreased to $29 $4 million from $30 million.

Noncash costs decreased to $2 9 million for the three months ending 30 September 'twenty, one from $3 5 million at the three months ending 30 September 2020, and this decrease is primarily related to share based compensation expense.

General and administrative expenses decreased to $8 3 million for the three months ending 30 September 'twenty, one from $9 8 million for the three months ending 30 September 2020, and cash costs, and just said it but I'll say, it again, which exclude depreciation expenses, where the share base.

<unk>.

Expense compensation expense decreased to $7 2 million from seven $7 million.

Christopher Vann: There was one further patient who developed a single lesion in the skin, which could be removed surgically, but obviously, that event was also considered a progression. No other patients progressed, and all other patients were in remission. Moving on to slide 18. Given Overcell's mechanism of action and profile, we're also evaluating its use in other B-cell malignancies.

Noncash costs and G&A decreased to $1 $1 million for the three months.

View from $2 1 million for the three months.

Gear.

And this decrease is also mainly attributable to share based compensation expense.

Other income expense increased by $3 5 million for the three months ending 30 September 2021 from an other expense of $2 5 million for the three months ending 30 September 2020 to other income of $1 million. This increase was primarily.

Christopher Vann: Non-hotrokinslin pharma patients as well as CLL patients are being evaluated as part of the extension of the Orkine study. We're also conducting in collaboration with our academic partners at UCL in the Carousel study, they use in primary CNS lymphoma, an aggressive lymphoma similar to DLBCL that is exclusively localized in the brain. In addition, as already mentioned, we're conducting an extension of the Carpel study with Auto 122 in pediatric patients. These studies, taken together, will give us a very good overview of the activity of oversell across the spectrum of CD-19 positive malignancies. Moving on.

Merrily due to the strengthening of the U S dollar relative to the pound during the three months period.

Income tax benefit decreased to five $4 million for the three months ending 30 September 2021 from $7 9 million for the three months of the corresponding period last year and that was due to a decrease in research and development expenditures, which qualified for the <unk>.

<unk>.

Yeah.

And as research and development credits fell at a faster rate than our net loss before income tax. This has led to a lower effective tax rate.

The net loss attributable to ordinary shareholders was $34 million for the three month period and that compares to $37 3 million for the same period last year the.

The basic and diluted net loss per ordinary share for the three months ending 30 September 2021 was <unk> 47 per share and that compares to a basic and diluted net loss per ordinary share of <unk> 72 cents.

Sure it could the corresponding period last year.

Christopher Vann: On slide 19, a brief reminder of the broad and exciting technology toolkit that we have developed in Autlis, particularly as it relates to the suite of next-generation programs, some of which we will record we showcased at the AACR last year. We're looking to move these programs forward into the clinic through 2021 and into 2022, including in our first solid tumor program. It's worth also reiterating the deal we recently signed with Moderna, which highlights the highly skilled in-house binder discovery team we have here in Autlis and the applicability of our work to other potential modality.

At this point, we estimate that our current cash on hand provides us with a cash runway into the first half of 2023.

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

Thanks, Andrew Let me conclude this part of the management discussion with a review of the upcoming milestones and news flow through the end of this year and into 2022, let's move to slide 24.

As you look at the remainder of this year and into next year. There are a number of clinical milestones and opportunities for value creation.

Key most imminent operational focus obviously is on the conduct of the pivotal field study with initial primary endpoint data expected around the middle of next year.

Christopher Vann: Finally, on slide 20, you can see that we have tabulated these next generation programs alongside expected phase one start dates. You will note, as discussed, we started the pediatric ALL clinical trial of Auto 122 in Q4 2020. We also expect the Auto 6NG study in GD2 positive solid tumulus to start enrolling in the first half of 2022. Auto 4 is also likely to move into the clinic in the first half of 2022.

Chris mentioned earlier, we are very encouraged barrel innovations that the CR rate and safety data on the multicenter phase one b part of the study is consistent with data reported from the academic old car 19 study of Ob sale, which as you remember it was conducted exclusively within the UK.

We plan to provide a little more detail on this initial clinical experience later this year at ash.

Further we expect to report an update from the Ob sell old car 19 extension trial, particularly from the remaining cohorts in the relapsed refractory non Hodgkin's lymphoma population as well as CLO patients again planned for the end of the year at Ash.

Christopher Vann: And finally, Auto 8, our next generation multiple myeloma product, will move into the clinic in Q4, 2021. With that, I'd just like to slide 21 and turn over the call to Andrew. Thank you. Thanks, Chris, and good morning or good afternoon to everyone.

We also are hopeful that we're going to be updating you on the <unk> one <unk> two phase one study in pediatric patients as well at that point in time.

In Q1 next year, we plan to provide an update on the phase one study called Carousel, where we are testing that will be settled in patients with primary CNS lymphoma, and then as we go through the remainder of the first half of next year. We also expect an update on the autos for clinical experience from term stretch.

Andrew Oakley: If we can move to slide 22, it'd be my pleasure to review our financial results for the third quarter of 2021. So if we start with our cash position, cash at the end of September totaled $173.1 million, and that compares to $216.4 million that we had at the end of June. I will note, however, that this cash figure does not include an R&D tax credit that we received in October of this year to the tune of approximately $25 million.

Relation portion of the phase one program.

As we then look forward into the next programs behind our lead programs.

We expect to obviously move several programs forward you heard from Chris Auto eight will get into the clinic still at the end of this year, we expect our.

Revised solid tumor program, where traditional self programming module sort of six LNG to get into the clinic.

Andrew Oakley: Net total operating expenses for the three months ending 30 September 2021 were $40.4 million, and that's net of grant income of $0.2 million. This compares with net operating expenses of $42.7 million, net of grant income of $0.4 million, for the same period in 2020. Research and development expenses decreased to $32.3 million for the three months ended 30th of September 2021 from $33.5 million for the three months ended 30th of September 2020.

During the third.

First half of next year and we're also moving all the ships four five.

Overall, we believe the company is in very good position combined with our cash on hand, we feel well poised for success across Schirmer pipeline, we're now happy to take questions operator.

To ask a question you will need to press star one on your telephone.

To withdraw your question press the pound key please.

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

Our first question comes from Mara Goldstein with Mizuho. Your line is now open.

Great. Thank you so much for taking the question.

Asked on this program.

You'll have.

The full data set in the first half of 2022, and then can you talk about just what the regulatory path is.

For that program and then on the <unk>.

Our extension studies, you said you want to gather the data and see where that information for you in terms of.

Andrew Oakley: Cash costs, which exclude depreciation and amortization as well as share-based compensation, decreased to $29.4 million from $30 million. Non-cash costs decreased to $2.9 million for the three months ending 30 September 21, from $3.5 million for the three months ending 30th of September to 2020. This decrease is primarily related to share-based compensation expense. General and administrative expenses decreased to $8.3 million for the three months ending 30 September 21 from $9.8 million for the three months ending 30 September 2020.

Looking at additional programs and so I'm curious as to how quickly you are able to execute on that once you have.

Alright data said I'm, assuming this year.

Andrew Oakley: And cash costs, and I just said it, but I'll say it again, which exclude depreciation expense as well as share-based compensation expense, decreased to $7.2 million from $7.7 million. The non-cash costs in G&A decreased to $1.1 million for the three months at review from $2.1 million for the three months prior year. And this decrease is also mainly attributable to share-based compensation expense. Other income expense increased by $3.5 million for the three months ending 30th of September 2021 from another expense of $2.5 million for the three months ending 30th of September 2020 to other income of $1 million. This increase was primarily due to the strengthening of the US dollar relative to the pound during the three-month period.

Mmm at two the the the Felix study and the program of <unk> in it all day on the Hill.

As you pointed out we expect reach the primary endpoint middle of the year that is based on complete remissions, the complete remission right and which is obviously established early on after treatment has started within these patients who will then by the end of the year Uhm expect too.

Andrew Oakley: Income tax benefit decreased to $5.4 million for the three months ending 30th September 2021 from $7.9 million for the three months of the corresponding period last year. And that was due to a decrease in research and development expenditures which qualified for the quarter. And as research and development credits fell at a faster rate than our net loss before income tax, this has led to a lower effective tax rate. The net loss attributable to ordinary shareholders was $34 million for the three-month period, and that compares to 37.3 million for the same period last year. The basic and diluted net loss per ordinary share for the three months ending 30 September 2021 was 47 cents per share, and that compares to a basic and diluted net loss per ordinary share of 72 cents per share for the corresponding period last year.

Also then have the six months follow up data on all of these patients and the expectation is that that will be the basis for the key regulatory filings that we're planning to do and those findings are currently projected to be happening in 2023.

Okay. Thank you I appreciate it.

Thanks, a lot ma'am.

Thank you. Our next question comes from <unk> Condie with Needham and company your lines now open.

[noise] Sean your line is open.

Hi can you hear me.

Hi, This is Michelle I'm on the phone.

Thanks for taking our questions can you give us any update on the soggy decorate flooring with all 384 of multiple myeloma turvy.

Believe you mentioned that you know you have thrown in D. C M. A and if you can give us any information about the second target.

Oh I'll pass on that can you give us any update on uncle five like obviously long.

No favours 34 to five enforcer, hoping I Gotta go thank you.

And you shall and and thanks for joining on Autophyte, obviously wanted a key things we're doing a super taking information for getting from all the four two and four in the the way we are going to actually conduct the study around altafaj sadosky information ever still collecting animals.

Into into the approach, we're taking with all the five.

Andrew Oakley: At this point, we estimate that our current cash on hand provides us with a cash runway into the first half of 2023. And with that, I'll now hand over the call to Christian to give you a brief look at expected milestones.

With regards to auto eight we have disclosed obviously that we have generated a very sensitive D. C. M. A card, which is a key component of the program and that is going to be initially tested and to establish the activity all that car on its own and at that point. Once that's established we're expecting to.

Christian Martin Itin: Thanks, Andrew. Let me conclude this part of the management discussion with a review of the upcoming milestones and newsflow for the end of this year and into 2022. So, let's move to slide 24.

Add a second antigen will disclose that at that point in time.

Thank you.

Thanks, a lot.

Thank you. Our next question comes from Nick Abbot with Wells Fargo. Your line is now.

Christian Martin Itin: As we look at the remainder of this year and into next year, there are a number of clinical milestones and opportunities for value creation. The key and most imminent operational focus, obviously, is on the conduct of the Pivotal Felix study, with initial primary endpoint data expected around the middle of next year. As Chris mentioned earlier, we are very encouraged by our observations that the CRAs and safety data on the multi-centre Phase 1B, part of the study, are consistent with the data reported from the actual academic old car 19 study of OB-cell, which, as you remember, was conducted exclusively within the UK.

Well good morning, Thanks for taking uhm question so.

First the.

First question Christian So we'll get an update on the old car. So it's a study later.

On this year and then very early next cable get the data pool or sorry, well it looks like I think it was the 122 data. So how do you choose between those two as it says you think about next steps beyond the adult Hello.

Uhm indication.

It's a very good question. They can bend thanks for joining in Joseph basically they're the underlying question you're asking is.

Uhm, what what is the profile and the opportunity you see in pediatric ALLL versus the opportunity you would see for Obi salvage some of the non Hodgkin's indications instead of the online I think element of the question.

Christian Martin Itin: We plan to provide a little more detail on this initial clinical experience later this year at Ashtra. Furthermore, we expect to report an update from the OBCEL-All-Car-19 extension trial, particularly from the remaining cohorts in the relaps refractory B, non-Hodgkins lymphoma population, as well as CLL patients, again planned for the end of the year at Ash. We're also hopeful that we'll be updating you on the Auto-122, Phase 1 study in pediatric patients as well at that point in time.

And so what we'd like to see obviously with the when we look at these indications we actually look at them independently cause there is I think the salt process around I order 122 is actually as part of the overall ALLL program that we're conducting with Obi sale with all we're looking at all the.

Oh 122 as the first next generation program that will expect to build up over time, and and obviously a pediatric yeah that'll being the key indication to establish the utility of having a C. D 22 card. It is highly effective to add it to the <unk> program. So so that program standards.

Christian Martin Itin: In Q1, next year, we plan to provide an update on the phase one study called COS cell, where we are testing OBCEL in patients with primary CNS lymphoma. And then as we go into the remainder of the first half of next year, we also expect an update on the Auto 4 clinical experience from the dose escalation portion of the phase one program. As we then look forward into the next programs behind our lead programs, we expect to obviously move several programs forward.

<unk> on its own feet in its own merit and one of the key things we wanted to see what that program is the reduction in the relapse rate in the pediatric patients and that's it for the the key entry point that we think would actually then trigger the full development uhm in pediatric ALLL, So that's sort of par.

Part of the overall, but if you think about it overall ALLL approach that we're taking and it's a component of it.

The opportunities that we look at four O b cell itself outside the a L. L. Space I think is a is a second question and I think of what we're going to understand is obviously, where can we see a profile that is is that stacks up noxious dwells, a potentially an improvement over and above.

Christian Martin Itin: You heard from Chris that Auto 8 will get into the clinic still at the end of this year. We expect our revised Solid tumor program with additional cell programming modules, Auto 6MG, to get into the clinic during the first half of next year, and we're also moving obviously forward with over the 5. Overall, we believe the company is in a very good position, and combined with our cash on hand, we feel well poised for success across our pipeline.

Of the other programs in the space in the additional non Hodgkin settings and this is what we're starting to explore with the extension program that we're doing on the old car study and roll that day that will help guide is actually two then the choices of the past that we're planning to develop within the non Hodgkin's indications.

So it's really going to be data driven but fundamentally we're looking at those two approaches I should've being separate and defenses auto 122 really being part of the overall Ada.

Operator: We're now happy to take questions, operator. To ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the Pound Key. Please stand by while we compile the Q&A Roth. Our first question comes from Mara Goldstein with Mizuha. Your line is now open. Excellent.

<unk> strategy that we're building up to you know build a significant presence in that in that indication set and and secondly, it's been done with a branching out into the broader don't Hodgkin's opportunities.

Perfect person and then maybe just the highlight to that movie is that the.

Mara Goldstein: Great, thanks so much for taking the question. Hey, I wanted to ask about the Felix program. You know, you'll have the full data set in the first half of 2022, and then you can talk about just what the regulatory path is from there for that program. And then on the all-car extension studies, you've said you want to gather data and see where that information takes you in terms of looking at additional programs.

UK manufacturing facility will support you know 2000 pesos random, which obviously will cover the adult L. L.

Indications.

What do you need to see and what was the timeline b for adding additional capacity to support for example, and then the phone number or.

P a O L.

Right. So the way we're building the capacity around the facility and in the U K gives is actually a very nice level of capacity and the ramp up ask for launching as a launching their yoga shell program and I think it will give us ample time to get a <unk>.

Mara Goldstein: And so I'm curious about this too, how quickly you are able to execute on that once you have, you know, the full data set, I'm assuming, this year. And then lastly, I apologize, but in your last comment, you said something about a revised solid tumor program, and I don't know if I heard the word revised incorrectly, so if you could just help me with that.

Feel for the trajectory and then also a feel for the timing for additional indications to come online today and actually time. The the Bill died not only off the facility in the U K, but also consider establishing uhm additional manufacturing capacity in the U S.

But it puts us in a very good space. It gives us a level of of capacity that we believe actually will it will put us in a very in a very good spot and I think when you look at the trajectory we seen in some of the other car T programs I think there's 2000, Mark I see that we believe is actually good mark to work with and and it gives us an ability.

Christian Martin Itin: Hi Mara. Great, great to hear your voice, and thanks for joining us. So Auto 6NG is, as you may remember, a program that we built on Auto 6, which is the original car, and we basically went back and re-engineered the program, and I probably should have used the term re-engineered. So there's no change absolutely consistent with what we have been reporting before. With regard to the Oil Car extension, obviously, what we're doing within the All-Car Extension is adding approximately 10 pages to this additional set of indications to get a feel for the activity of the program within those indications.

[noise] reaction time.

Okay that day, so that both of them for me is.

Two pasta so could you provide us with an update on the M. O D posted cohort Felix and also they're comparing the sort of milestone slides back to previous ones, we're not saying mention of I'd also aloe or so seven programs.

Programs and the current slide can you provide some lettuce, what what the status of those programs as well. Thank you.

Right. So so the other approaches continuing obviously with our in our collaboration with the with our academic partners. So that's slated to go in the first half of next year and the the order of seven program. We're planning to run in sequence to auto six N G. We want to get into <unk>.

Christian Martin Itin: That works is ongoing. And obviously, depending on the indication, we would like to have a certain amount of follow-up to understand the level of differentiation of the data that we can actually see across these various indications, and we'll be guiding accordingly as we go through the course of next year. Getting to the Felix study and the program of OB-Cell in adult ALL, as we pointed out, we expect to reach the primary endpoint in the middle of the year that is based on complete remissions, the complete remission rate, and which is obviously established early on after treatment has started in these patients, who will then, by the end of the year, expect to also then have the six-month follow-up data on all of these patients Okay, thank you. I appreciate it.

<unk> around the various modules reintroducing into <unk> into that program, which also also part of the all the setup program.

So there will be a spanking and that we expect to that run between those two so that you have programs.

So I think that's.

Think that was the.

Fatality other questions or did I Miss anything.

Yeah, we're just on the M O D posted cohort, how that's going Oh, damn or deep home decor I guess.

So so the NRT positive court is obviously part of the Felix study Enrons alongside Felix study.

I'm and I'm sure it will be will be giving updates as we go through the course of next year on that patient food, but right now all of a sudden enrollment focus is is very much on the then relapsed refractory population with morphological 40 laps.

Great. Thanks, a lot for pull it to ash.

Okay excellent. Thanks, a lot make thanks for joining.

Thank you. Our next question comes from Africa. Good morning, with truths Securities. Your line is now.

Christian Martin Itin: Thanks a lot, Mara.

Operator: Thank you. Our next question comes from Nishant Gandhi with Needham and Company. Your line is now open.

Hi, guys. Thanks for taking my question.

I just want to connect back on that little Easter egg you dropped about.

Nishant Gandhi: Hi, this is Mishas. I'm on for, and thanks for doing our questions. Can you give us any updates on the target that you're exploring with Auto8 for multiple myeloma therapy? I believe you mentioned that, you know, you're exploring B-CMA, and if you can give us any information about the second target. Apart from that, can you get on Auto5? Like, I will still be on Transitiate Phase 34 Auto5 in Postal 428. Thank you. Any Sean, thanks for joining us.

Giving up a little bit of a view on T O X at Ash, Kate when it comes with a little bit more about that English presentation will that be and number of patients et cetera that we could expect and then on that topic of asking you. Maybe also give us a little bit more color on the number of patients we should be expecting to order one and then H R. T O L as well as.

Order 122, thank you.

Sure. Thanks for joining us account so when we look at the what we're planning to do with regards to the faithful B portion obviously the key questions that we're asking with the phase on beef portion was really to move from a.

Christian Martin Itin: Sean, thanks for joining us. On Auto 5, obviously, one of the key things we're doing is that we're taking information we get from Auto 4 to inform the way we're going to actually conduct the study around Auto 5. So that's key to the approach we're taking with Auto 5. With regard to Auto 8, we have disclosed, obviously that we have generated a very sensitive BCMA car, which is the key component of the program, and that is going to be initially tested to establish the activity of that car on its own. And at that point, once that's established, we're expecting to add a second antigen; we'll disclose that at that point in time. Thank you. Thanks a lot.

Single country, almost single Center study, which is what the old car study is to a multicenter multi country country environment and with that obviously and a significant increase in complexity and logistics into everything else. So so that was the goal is to really make sure we're demonstrating that <unk>.

And with demonstrating that we're replicating the.

The data or she will also move to commercial supply for vector and so on and so there's a few changes that we made along the way to sort of transition to program into commercial stage.

Alright, a towards commercial station, that's sort of one of the key topics that we expect to update.

Dash and then a context also with a share key aspects of the phase one b trials that we've conducted which obviously was designed to confirm the activity level that we've seen at your <unk> does it the the old car study. So so that update will be given will will give that that.

Operator: Thank you. Our next question comes from Nick Abbott with Wells Fargo. Your line is now open.

Nick Abbott: Good morning, thanks for taking our questions. So the first question, so we'll get an update on the all-car extension study later this year, and then very early next year, we'll get the data for, or sorry, we'll also get the 122 data. So how do you choose between those two assets as you think about next steps beyond the adult ALL indication? It's a very good question, Nick, and thanks for joining us.

Experienced which I think is important as we indicated the data that we're seeing is consistent in terms of the key parameters that we're looking at which is where you lay around safety one of us will be sure. We replicate the safety, but also replicating the overall activity in there and that's where the the highest Ah kind of high level statement that we made today and throw up.

<unk> got a shelter corresponding data to that.

When we look into the updates around it the old car 19, <unk> 19 study and actually moving into the non Hodgkin side. What we did is we are added additional cohorts space 10 patients at each and we're going to give an update on the progress the exploration of on these various cohorts uhm and somebody.

Christian Martin Itin: And so basically, the underlying question you're asking is, what is the profile and the opportunity you see in pediatric ALL versus the opportunity you would see for OB-Cell and some of the non-Hodgkin's indications? It's sort of the underlying, I think, element of the question. And so what we'd like to see, obviously, when we look at these indications, we actually look at them independently because there is, I think, the thought process around Auto-122 is actually as part of the overall ALL program that we're conducting with OB-CEL, with all we're looking at Auto-122 as the first next-generation program that will build up over time.

Some of it at the courts will be.

Fully bold this will still be enrolling so we'll see basically a snapshot password transitioning through those datasets as you go through the end of the year and then on the Pediatrics study, obviously will give us an overview on the overall program I keep track joysticks et cetera, but also kind of some chai.

Some of the initial clinical data uhm on that program. The key update would expect actually for the <unk> for the pediatric program will be towards the middle of next year. When we have about six months of follow up for for a visit that the patient group, which is we believe gives us a good feel for have a tracking with regards to the ability to men in my.

Christian Martin Itin: And obviously, pediatric ALL is the key indication to establish the utility of having a CD-22 car that is highly effective added to the OB-Cell program. So that program stands on its own feet and its own merit, and one of the key things we want to see with that program is a reduction in the relapse rate in pediatric patients.

<unk> indicates once they achieve response, so that says a as it's just a framework I think it's instead of framing expectations for the end of the year.

Got a question if I may just add though in and this data that you talk about in terms of transitioning auto wanting to commercial stage here Uhm. This president's day, but what what should be showing a basketball that'd be a tool patient level data from <unk> study then in this.

Christian Martin Itin: And that's sort of the key entry point that we think would actually then trigger the full development of pediatric ALL. So that's sort of a part of the overall, if you think about the overall ALL approach that we're taking, and it's a component of it. The opportunities that we look at for OB-Cell itself outside the ALL space, I think is a second question.

Conditions.

Well the date I've ever please be sharing obviously is exclusively from the face mom b portion.

Because as you can imagine you do not want to share pivotal date head of actually getting the study completed and everybody treated.

So this will be will be focused on the one b experience off the study.

Got it thank you very much for that contest.

Alright, Thanks, a lot appreciate it.

Thank you. Our next question comes from that fits with William Blair. Your line is known.

Christian Martin Itin: And I think what we want to understand is, obviously, where can we see a profile that stacks up not just well, but potentially as an improvement over and above the other programs in the space in the additional non-hachkin settings? And this is what we're starting to explore with the extension program that we do on the old car. study, and that data will help guide us actually to then the choices of the past that we're planning to develop within the non-Hodgkins indications.

They for taking my questions you know I guess, Christopher we've had a couple of states in the third quarter with some city 19 knowledge at a car T programs and Wonder if you have any other thoughts on those this is kind of influencing any of your allergenic approach, which I believe is not fully knockout. The P. C. R. If I'm remembering correctly, if somebody's yokota.

Fisher.

Hey, Mac and.

Thanks for the question, obviously, there is a limit to what we know about what's going on in those programs. Obviously, there being some public statements that I think most of you have commented on I think most most of the coal actually are covering probably the companies involved. So I think we're seeing obviously emerge.

Christian Martin Itin: So it's really going to be data driven, but fundamentally, we're looking at those two approaches as sort of being separate in the sense that Auto 1.22 is really part of the overall ALL strategy that we're building up to, you know, build a significant presence in that indication set. and secondly, it's then the branching out into the broader on Hoskins' Okay, thanks, Kristen, and maybe just allied to that, you said the Initial UK Manufacturing Facility will support 2,000 patient Franum, which obviously will cover the adult ALL indications. What do you need to see and what would the timeline be for adding additional capacity to support, for example, a lymphoma or PDAO?

<unk> data, which I think is interesting and so that gives us a sense of the.

The the performance of the production with expect more updates also around dash and I think that's a development in its own right. Obviously, the various ways of technology and some of the players were pointing to elements of their technology that might give them an element of potential differentiation uhm either on efficacy or safety.

I don't think I want to comment on that the approach, we're taking with regards to the program or exploring with with our academic partners is really too track.

T cell receptor within the secret Tori pathway.

So in other words, what we're doing this for basically expressing a protein molecule that actively traps the actual protein TCR protein within the Shaker Tori pathway and Sean fit into the degradation pathways now that's a fundamentally different approach to any approached it actually aimed to knocking or knock out jeans in whatever way that picking.

Christian Martin Itin: Right, so the way we're building the capacity around the facility in the UK gives us actually a very nice level of capacity in the ramp-up as we're launching the Yoga Cell program. And I think it will give us ample time to get a feel for the trajectory and then also feel for the timing for additional indications to come online to then actually time the build-out not only of the facility. in the UK but also consider establishing additional manufacturing capacity in the US.

Of all that she actually gasp that so it's a different approach we're not operating at the at the in that sense at the genome level before Oprah operating with at the at the protein level and so there's a sort of a it's quite a different technological approach that we're taking uhm here, but I don't want to get.

Let you speculate on the on the current technologies and play with without the companies I think that will update I think the field.

Christian Martin Itin: But it puts us in a very good space. It gives us a level of capacity that we believe will actually put us in a very good spot. And I think when you look at the trajectory we've seen on some of the other CART programs, I think the 2000 mark is actually a good mark to work with, and it gives us an ability to react. Okay, thanks, and then. The last one for me is a two-parter, so can you provide us with an update on the MRD positive cohort of Felix?

At the upcoming conference season, I think we'll learn what's going on there the other day in that context.

Great. Thanks Christian.

Thanks, Matt.

Thank you. Our next question comes from Kelly, She with Jeffries. Your line is now.

Hi, Thank you for taking my question. This is Dave on four Kelly had Jeffries. So my question is regarding auto once Alex beyond Ottoman Feliks, an adult L. Do you see the possibility that the F. D. A might ask for randomized control trial instead of single I'm trial given the.

Christian Martin Itin: And also, you're comparing the sort of milestone slides back to previous ones. We're not seeing mention of either the auto-allo or auto-7 programs in the current slide. Can you provide some, you know, let us know the status of those programs as well?

Involvement of a complicated landscape.

And the second question is can you said expectation on data and first quarter of next year for primary CNS lymphoma.

Thank you.

Hey, Thanks, a lot for joining uhm with regards to.

Nick Abbott: Right, so the other approach is continuing, obviously, in our collaboration with our academic partners, so that's slated to go in the first half of next year. And the Auto 7 program, we're planning to run in sequence with Auto 6NG. We want to get some experience around the various modules that we're introducing into that program, which is obviously also part of the Auto 7 program. So there will be a stake that we expect to run between those two Solituma programs. So I think that's, I think that was the fatality of the questions, or did I miss anything?

Felix study.

The first of all in terms of the.

The way that the the.

The study obviously, it's designed it's designed to give us the complete remission right out of a single Orange study.

When we look at the history of recent approvals within ALLL, we have down the street <unk>, which was approved.

Single arm study approximately 100 patients we have now the approval off to Carter's in it all day and they all with just 54 patients missing alarm study and we expect that there is no change that will see here. So we expect that string alarm study with the level of robust data that we have seen in.

Early experience.

<unk> is absolutely adequate to submit uhm four or apply for registration for the program I don't think that is entirely consistent with what we've seen before was seeing the same old from the pediatric an outside and all the signal also seen it in the the various trials that led to approve.

Christian Martin Itin: Yeah, just on the MRD positive cohort, how that's going. Oh, the MRD positive cohort, yes. So the MRD positive court is obviously part of the Felix study and runs alongside the Felix study, and I'm sure we'll be giving updates as we go through the course of next year in that patient pool. But right now, obviously, the enrollment focus is very much on the relapse refractory population for morphological reasons. Great, thanks a lot, I look forward to Ash.

<unk> space, which is obviously much smarter space and the programs not showing much differentiation actually between themselves. So I don't think there's any change there I think the fact that indeed the card has got a full approval for relapsed refractory independent offline I think is a very good is very poor.

Nick Abbott: Excellent. Thanks a lot, Nick. Thanks for joining us.

Operator: Thank you. Our next question comes from Othaca, Gung Wardeen, with True Securities. Your line is now open. Hi, guys, thanks for taking my question.

That if development I think bodes well for all central around program and so I think we're in a very good place there.

Thank you.

Thanks, you guys.

Our next question comes from Eric Joseph J P. Morgan Your line is no.

Asthika Sarith Goonewardene: and Christian, I just want to connect back on that.

Thanks for taking my question.

Christian Martin Itin: The Easter egg you dropped around, giving us a little bit of a view of Felix at Ash. Can you maybe talk a little bit more about that? In which presentation will that be?

Maybe just a housekeeping one related to the upcoming big or B, you excrete out I guess.

How can you be thinking about.

What might be included in a submitted abstractly COVID-19.

The second sort of material data there is it mostly a boat builder and then secondly, I'm wondering if you could give us a bit of a <unk> progress update with the base to set of course.

Asthika Sarith Goonewardene: and number of patients that we could expect.

Uhm and are patient is that these will be.

Asthika Sarith Goonewardene: And then on that topic of Ash, can you maybe also give us a little bit more color on the number of patients we should be expecting for Order 1 in NHL and CLL as well as Order 122? Thank you.

Completely just the state.

The.

Our patients in the phase one or Facebook Facebook be distributed all through the <unk> redecorate are expecting over the course of the next year or just a question of operation.

Christian Martin Itin: Sure, thanks for joining us, Kat. So when we look at what we're planning to do with regard to the Phase 1B portion, obviously, the key question that we're asking with the Phase 1B portion was really to move from a single country, almost single-center study, which is what the All-Car study is, to a multi-center, multi-country environment. And with that, obviously, you know, a significant increase in completeness and logistics and to everything else.

Well thank.

Thanks for joining thanks for the question so that obviously the way that we designed to study.

Does not make any distinction of differentiation in terms of inclusion criteria between the face won't be in the face too.

So we're enrolling the exact same patients uhm into the phase two portion as we have enrolled into the phase one b portion and that's obviously one of the values of the phase one P data that it actually gives us a good read not only the inclusion exclusion that's a different factories sticks with the patient.

But also it also it also enrolls the patient at the centers that were involved in the majority of the centers in phase one fever, and the U S and we're enrolling patients in the U S. So it reflects very well what we expect the composition of the patients be in the interface to portion send that central belief that the the data acts.

Christian Martin Itin: So that was the goal to really make sure we're demonstrating that transition. We're demonstrating that we're replicating the data. We've also moved to commercial supply for vectors, and so on.

Christian Martin Itin: So there are a few changes that we made along the way to sort of transition the program into the commercial stage, towards the commercial stage. And that's sort of one of the key topics that we expect to update on at Ashin. And then we will also share, you know, key aspects of the Phase 1B trial that we conducted, which was designed to confirm the activity level that we saw during the Ovalcar study.

<unk> is is very meaningful money's important in that context and it also obviously includes as I indicated before complexities related to logistics et cetera, which all obviously have an impact on on your banks delivery time on its own. So for so it gives you that overall a level of consistency across and southern Baptist.

Fact is we expect the data to be you know.

Very helpful and a very good guidance as we go forward. It the other way I actually I think that is worthwhile thinking about the data is that this is now going to be the third chair to stay down that will become available around obi sale in ALLL. We obviously have the first date of second a pediatric ALLL population.

Christian Martin Itin: So that update will be given. We'll give that experience, which I think is important, as we indicated. The data that we're seeing is consistent in terms of, you know, the key parameters that we're looking at, which are really around safety. We'll also be sure we replicate safety.

Which is obviously was published in nature Medicine. We then have the experience in the adult population of the old car setting.

Christian Martin Itin: but also replicating the overall activity, and that's sort of the high kind of high-level statement that we made today. And we're obviously going to show the corresponding data corresponding to that. When we look into the updates around the Ocar 19 study and actually move into the Noh-Hodgkin site, what we did is we added additional cohorts with 10 patients each, and we're going to give an update on the progress of the exploration around these various cohorts.

Adding the experience in the Felix for a small portion and I think that's another way of looking at the data and actually just looking at the at the level of consistency of the data across data sets, which I think is another way to sort of actually get understand onto a good understanding of the profile of the product and and I think an understanding consistency.

Uhm between between these various slightly different populations, but of course as I indicated that won't be population is the same population that the phase II population actually is but I think that's part of the reason I think what are the key opportunities.

Christian Martin Itin: And some of the cohorts were fully involved, others will still be enrolling, so we'll see basically a snapshot as we're transitioning through those datasets as you go to the end of the year. And then on the pediatric study, obviously, we'll give an overview of the overall program, key characteristics, et cetera, but also kind of share some of the initial clinical data on that program. The key update we'll expect for the pediatric program will be towards the middle of next year when we have about six months of follow-up for the patient group, which we believe gives us a good feel for how we're tracking with regards to the ability to minimize relapses in the case once the achievales have healed.

Certainly I think actually spoke a little bit fishing I just wanted to clarify that the.

The phase one basis Rover.

Comprise the cohort were looking at it face to that the reader, Oh, I see paycheck, but I'm gonna be getting a yep.

Yeah, No no district speech, a distinct in terms of actual data set. So there is a faithful and be datasets, there's a phase two dataset and there I was actually there are two datasets I mean, what you did see when you looked at the car just Uhm review that the F. D. A date the FDA actually took into account extra.

Phase one experienced with the card is at least in some aspect. Some safety. That's what we've seen circling that dataset. So there may be some view broader view on safety, but from an efficacy perspective, we expect that that will be focused on the face to take effect alone.

Christian Martin Itin: So that's just a framework, I think, is sort of framing expectations for the end. Got a question. And if I may just add, so in this data that you talk about in terms of transitioning Auto 1 into a commercial stage here, this present, what should be showing on the dashboard? Will there be actual patient-level data from the Felix study then in this presentation? Well, the data that would be shared, obviously, is exclusively from the phase 1B portion because, as you can imagine, you do not want to share pivotal data ahead of actually getting the study, you know, completed and everybody treated.

Okay. So just an update on or can you give us a progress with it well within the ACB.

About the you know the size and receive a follow up on me.

And the imager readout broke the space too.

Thinking about that.

Right. So so the what we're guiding a sniper expect studied to be.

Fully enrolled during the course of the first half of next year with the primary endpoint waiting out in the middle of next year.

So that's the guidance the primary endpoint is established by two measurements one measurement at one month and then a confirmatory measurements at two months after dosing and in both cases in order for a <unk> to be counted as a C or you want to see our to be actually established at both time points.

Asthika Sarith Goonewardene: So this will be focused on the 1B experience. Got it. Thank you very much for that, Colin Christian. All right, thanks a lot. I appreciate it. Thank you. Our next question comes from Matt Fitz with William Blair. Your line is no. Thanks for taking my questions. You know, I guess, Christian, we've had a couple of estates in the third quarter with some CD19 oligenic Cartier programs, and wondering if you have any high thoughts on those, and if this is kind of influencing any of your allergenic approach, which I believe does not fully knock out the TCR, if I'm remembering correctly my recollection of the UCL presentation.

And that actually goes into the assessment of the primary endpoint.

And so so that's the key the key data you have at that point and then obviously the full follow up of these patients uhm eastend, where the dish with old patient six months photo will be expected to read out it towards the end of next year.

Okay, Great and then final question are you, providing further updates burger follow up.

From the adult ALLL cohort of all car Macy.

You know either.

Back to our complaint for you.

We expect to do that obviously, we are updating.

Hoskins experience and there's an opportunity to to update on the durability data.

Matthew Gitlin: from the UCL presentation. Hey, Matt, and, you know,

Christian Martin Itin: Hey, Matt, and thanks for the question. Obviously, there is a kind of limit to what we know about what's going on in those programs. Obviously, there have been some public statements that I think most of you have commented on. I think most of the statements on the call actually are covering probably the companies involved. So I think we're seeing, obviously, emerging data, which I think is interesting and sort of gives us a sense of the performance of the products, and I would expect more updates. It's also around Ash.

Okay, great. Thanks for taking the question.

Thanks, a lot Eric.

Thank you. Our next question comes from guilt Bloom with medium <unk> Company. Your line is now.

Hi, everyone and thanks for taking a question just a quick one on on the phone.

There's been some pretty good results for apologist parties and other programs for ourself.

Maybe you could kind of.

Put in context for us how important it is to have an apologist option that is relatively safe and this particular location population. Thank you.

[noise], Thanks, Gail and thanks for joining it's a really good question I mean, one of the interesting things about Follicular lymphoma, if you compare it to the ALLL setting that were actually say and they step in Follicular lymphoma, you have basically an indolent disease. So a disease that is relatively slowly progressing red.

Christian Martin Itin: I think that's a development in its own right. Obviously, the various ways of technology, and some of the players were pointing to elements of their technology that might, you know, give them an element of potential differentiation, either on efficacy or safety. But I don't think I want to comment on that.

Is it really slowly growing.

And but it is a disease that we actually have no way at this point to cure. So everything we do in that disease setting is designed to buy time now we do have many options for these patients uhm. They have obviously a lot of chemotherapy backbones combined with biological sister the mainstay of the options that are available to those pay.

Christian Martin Itin: The approach we're taking with regard to the program we're exploring with our academic partners is really to trap the... the T-cell receptor within the secretory pathway. So in other words, what we're doing is basically expressing a protein module that actively traps the actual TCR protein within the secretory pathway and jumps it into the degradation pathways. Now, that's a fundamentally different approach to any approach that actually aims to knock in or knock out genes in whatever way that technology actually does that.

<unk> buying them.

Uhm of time, but not curing actually the patients along the way what they do experience is obviously the level of third enough toxicity, but also quote unquote. The convenience of a lot of these therapies to obviously be administered and I patient settings. So they typically don't have to go.

[noise] to a hospital to be treated get managed actually in the parade race for the most part so that's sort of the settings. So what did you need in order to sort of actually reached his patients I think there's two things first of all you wanted to actually be able to show that indeed, you have the safety profile, where the patient can get treated.

Christian Martin Itin: So it's a different approach. We're not operating at the, in that sense, the genome level, but we're operating at the protein level. And so there's quite a different technological approach that we're taking here, but I don't want to get, you know, speculate on the current technologies in play with other companies. I think they will update the field at the upcoming conferences, and I think we'll learn what's going on there in that. Thanks, man. Thank you. Our next question comes from Kelly Shee with Jeffries. Your line is now open.

In much more into the <unk> and certainly in an outpatient setting because that is sort of what they use and what they're comparing two secondly, I think you would want to see longterm permissions in these patients. So that indeed. This one time intervention gives you a meaningful amount of time, hopefully, but that data is still out.

Operator: Hi, thank you for taking my question. This is Dave on behalf of Kelly Sheet Jeffries. So my question is regarding Auto1 Felix. Beyond Otto and Félx in Adult AAL, do you see the possibility that FDA might ask for a randomized control trial instead of a single-arm trial given the evolution of the competitive landscape? And second, can you set expectation on data in the first quarter of next year for primary sight in this lymphoma?

Standing in a field converting some of these patients into into cures and what are you really need to look at it when you look at it from the patient's perspective is that you have on the one hand and your your standard chemo biological backbone, which means that you're gonna get treated every every 234 weeks and you're going to go back and you're gonna get.

<unk> series of Chemo is you get another load of of antibody of some sort and you just keep doing that and so you have to do that on an ongoing basis until you relapse and all of these treatments are designed to be treated Ah are you to actually provide treatment until relapse I think the opportunity for car team that.

Dave: Dave, thanks a lot for joining us with regard to the Felix study. First of all, in terms of the way that the study obviously is designed, it's designed to give us the complete remission rate of a single-armed study. When we look at the history of recent approvals within ALL, we have, obviously, Blenatumab or Blin phyto, which was approved in a single-arm study of approximately 100 patients. We have now the approval of Tricardis in Adalt, ALL, with just 54 patients in a single-arm study.

Field would be to to have an opportunity to get a meaningful.

Response and adjustment of the disease through a single a single intervention and then actually has you know hopefully a year to several years, maybe longer where you don't need additional intervention I think that is part of the arch activity. It's also when you think about it from a cost perspective the fan.

Christian Martin Itin: And we expect that there will be no change that we'll see here. So we expect that a single-arm study with a level of robust data that we have seen in our early experience is absolutely adequate to submit for or apply for a sort of registration for the program. And I think that is entirely consistent with what we've seen before. We've seen the same on the pediatric ALL side. And obviously, we've also seen it in.

Fact that the regiments are given until relapse honestly rack shop, a lot of cost over time.

And that's what's driving a lot of the revenue lines that we see in the space I think also in that context, that's very costly and if you can actually have a one time intervention. There's a lot of treatment associated costs that obviously you could take out of the equation. So there's also I think an interesting economic argument to be made a.

A very strong left from a patient perspective of having sort of a single intervention that then actually you know keeps you keeps you in good shape for an extended period of time as well as I think an element of ultra patient management costs. That's there until when we look at in terms of the profile for a product I think you'd want to have a product that has and ability.

Christian Martin Itin: the various trials that led to approvals in the DOVCL space, which is obviously a much larger space, and the program is not showing much differentiation actually between these. So I don't think there is any change there. I think the fact that indeed, the card has got a full approval for relaps, refractory, independent of line, I think is a very good, is a very positive development. And I think it bodes well for us and for our program. And so I think we're in a very good place there. Thank you. Thank you, guys. Our next question comes from Eric Joseph with J.T. Morgan, your line is

To actually have a very good safety profile is very low manageable, but that is scant combined with an ability to sustained pressure on the lymphoma, because that's in essence, what any other therapy dosage maintaining pressure on the lymphoma that.

In order to do that you also would actually ask off the <unk> off the car key therapy to have an extended uhm persistent so that indeed, you're able to actually put a longterm pressure on the lymphoma and sustained out over time to either convert the patients into longterm relations. So I think those are public.

Operator: Thanks for taking the question. Maybe just a housekeeping one related to the upcoming phase one, the Felix Frida. I guess, how should we be thinking about what might be included in a submitted abstract? Should we be expecting sort of material data there as it loves you, a payholder? And then, secondly, I'm wondering if you can give us a bit of an idea.

Two key correct jurisdiction and I will say, it's one of the key features that we're seeing in our program.

In in probably the most challenging the resetting which is D. At all day and I will population and we do see that very nicely. Those two features and that's why we're interested in exploring that obviously in the context off the the initial experience in the old course.

Eric William Joseph: and progress update on the phase two study quotient. And our patients in phase one B, completely distinct from the Are patients from phase 1, or patients from phase 1B contributing to the Phase 2B redads that we're expecting over the course of the next year, or are they completely distinct patient populations? Well, thanks Elliot for joining, thanks for the question.

Mr May maybe a related question. So we've been seeing the allergen the space, particularly in <unk> I'm moving towards.

Multiple doses of the solar therapeutic room, so involving additional chemo.

Think that this might provide that kind of an opening.

Again for for an apologist Carty therapy with a better safety profile like what you had with auto Street.

Christian Martin Itin: So obviously, the way that we designed the study does not make any distinction or differentiation in terms of the inclusion of criteria between the phase 1B and the phase 3. So we're enrolling the exact same patients into the phase two portion as we have enrolled into the phase 1B portion. And that's obviously one of the values of the phase 1P data, that it actually gives us a good read on not only the inclusion, the inclusion and the characteristics of the patients, but it also enrolls the patients at the centers that we're involving, the majority of the centers in phase 1B are in the U.S., and we're enrolling patients in the U.S.

I think well I think first of all it's I think it's a very interesting question and what we're seeing in you know I think matched ask the question before slightly different way and is that we're seeing that the data start to actually come forward in terms of some of the other genetic approaches and and the fact that many of the companies talk about it.

Multiple doses.

Heading towards.

While there is activity in order to sort of get a more sustained activity, India Bcl patients, which is really unique to get frankly, you have to get you to a certain level of killers and these patients to make your therapy worthwhile.

But that May may take a few more steps and of course, the more you add in terms of those things and reconditioning natural and so forth.

Christian Martin Itin: So it reflects very well what we expect the composition of the patients to be in the phase two portion. So in that sense, we believe that the data actually is very meaningful and is important in that context. And it also obviously includes, as I indicated before, complexities related to logistics, etc., which all obviously have an impact on your bank's delivery time and so on and so forth.

You add complexity to the therapy add complexity from the management perspective complexity from a treatment could perspective, and you take the way differentiation from a frankly a standard chemotherapy.

Chemotherapy antibody drop conjugated antibody type of combination approach that that you also or by specific approach that is also activeness space and I think that's one of the.

Christian Martin Itin: So it gives you that overall level of consistency across. And so from that perspective, we expect the data to be, you know, very helpful and very good guidance as we go forward. And the other way, actually, I think that it is worthwhile thinking about the data is that this is now going to be the third set of data that will become available around OB Cell in ALL. We obviously have the first data set in the pediatric ALL population, which was published in Nature Medicine.

The key questions will be and what is the switch standalone activity and and can you really differentia itself differentiate yourself away with those approaches from other approaches like I'm trying to being pushed where we do see is that still the level of a sustained gr's that are seeing other car T side of the autologous Carty site at.

This point at least has not been matched by any other therapeutic modality and I think that I think certainly creates an opening and two part of the comment I made before to buy a follicular lymphoma.

Having a good safety profile will be important in order for patients to really getting access to the therapy because those patients as we pointed out as many times during the course of the last 24 months or so tend not to be treated at the academic hospitals in D. O D feel they're actually much more further out into the periphery and.

Christian Martin Itin: We then have the experience in the adult population, the old car setting, and we're now adding the experience in the Felix phase 1B portion. And I think that's another way of looking at the data and actually just looking at the level of consistency of the data across the data sets, which I think is another way to sort of actually get a good understanding of the profile of the product and, I think, an understanding of consistency between these various, slightly different populations, but, of course, and as indicated, the 1B population is the same population as the phase two population. I think that's where the real value is, and I think that's where the key opportunity is.

And with that you'd need a productive actually have stripped good a good level of safety and those are obviously hallmarks. We're seeing both received with all of the three and we're now obviously exploring with auto loan Amish <unk> and I think we're going to get a very good field, where that's gonna go but.

Certainly, there's more complexity and a D O D C L space them properly I think many folks anticipated earlier this year.

Alright, Thank you for taking our questions and.

That's on the continued progress.

Christian Martin Itin: Certainly, I think I actually misspoke a little bit, Christian. I just wanted to clarify that the, um, none of the phase one,

Thanks, a lot much appreciate it.

Thank you I'm showing no further questions at this time I would now like to turn the conference back over to a Christian item.

Eric William Joseph: Patients roll over or

Alright, well thanks, everybody for joining much appreciate you took the time today Uhm and we're looking forward to obviously update to you around the alright, the ash meeting and looking forward to an exciting 2022 and with that I'd like to thank you all and looking forward to connecting hopefully in person not too far right.

Eric William Joseph: comprise the cohort you're looking at in phase two, that the read out,

Christian Martin Itin: Oh, I see. Okay, I'll take it.

Eric William Joseph: Yeah, no, these are distinct in terms of actual data sets. So there is a phase 1B data set, there is a phase 2 data set, and there are actually two datasets. I mean, what you did see when you looked at the Tachardis review that the FDA did, the FDA actually took into account phase one experience for Tickardis, at least in some aspects of safety. That's what we've seen, certainly in that data set. So there may be some views, a broader way, on safety, but from an efficacy perspective, we expect that that will be focused on the phase two data set. Um

Thanks, a lot bye bye.

This concludes today's conference call.

Thank you for participating you may now disconnect.

[music].

Christian Martin Itin: So just an update on or can you give us a progress update on enrollment in the FACB and, if we're just kind of think about the size and duration of follow-up in the mid-year readout from Felix FACE

Eric William Joseph: From Felix phase two, I guess, how should we be thinking about that? Right, so what we're guiding is that we expect the study to be fully enrolled during the course of the first half of next year with the primary endpoints reading out in the middle of next year. So that's the guidance.

Christian Martin Itin: The primary endpoint is established by two measurements, one measurement at one month and then a confirmatory measurement at two months after dosing. And in both cases, in order for a CR to be counted as a CR, you want the CR to be actually established at both time points. And that actually goes into the assessment of the primary end goal. And so that's sort of the key data you have at that point. And then obviously, the full follow-up of these patients is then with additional, where all patients, six months of follow-up will be expected to read out towards the end of next year.

Eric William Joseph: Okay, great. And then the final question, are you providing further updates, further follow-up, from the adult ALL cohort?

Eric William Joseph: Hort of Alcar 19.

Eric William Joseph: You know, either at Ash or we expect to do that.

Christian Martin Itin: Right, we expect to do that. Obviously, we're updating the Nol-Hashkins experience, and there's an opportunity to sort of update the durability data. Thanks for taking the question. Thanks a lot, Eric.

[music].

Eric William Joseph: Thank you. Our next question comes from Gil Bloom with Needham and Company. Your line is now over.

Operator: Hi, everyone, and thanks for taking our question. Just a quick one on indolent lymphoma. There have been some pretty good results for orthologists, CAR-T, and other programs for FL. Maybe you could kind of put in context for us how important it is to have an otologist option that is relatively safe in this particular patient population. Thank you. Thank you, and thanks for joining us.

Gil Joseph Blum: It's a really good question. I mean, one of the interesting things about follicular lymphoma, if you compare it to the ALL setting that we're active in, is that in follicular lymphoma, you have basically an indolent disease, so a disease that is relatively slowly progressing, relatively slowly growing, but it is a disease that we actually have no way at this point of treating. So everything we do in that disease setting is designed to buy time.

Gil Joseph Blum: Now, we do have many options for these patients. They have obviously a lot of chemotherapy backbones combined with biologicals, just the mainstay of the options that are available to those patients, buying them, you know, years of time, but not actually curing them along the way. What they do experience is obviously the level of burden of toxicity, but also, quote, unquote, the convenience of a lot of these therapies being obviously administered in outpatient settings, so they typically don't have to go into a hospital to be treated, but they can get managed actually in the periphery for the moment. So that's sort of a setting.

Christian Martin Itin: So what do you need in order to sort of actually reach these patients? I think there are two things. First of all, you want to actually be able to show that indeed you have a safety profile where the patients can get treated much more on the periphery and certainly in an outpatient setting because that is sort of what they're used to and what they're comparing to. Secondly, I think you would want to see long-term remissions in these patients so that, indeed, this one-time intervention, you know, gives you a meaningful amount of time.

Christian Martin Itin: Hopefully, but that data is still outstanding in the field of converting some of these patients into into And what you really need to look at when you look at it from a patient's perspective is that you have, on the one hand, your standard chemobiological backbone, which means that you're going to get treated every two, three, four weeks, and you're going to go back in, you're going to get another series of chemo And so you have to do that on an ongoing basis until you relapse, and all of these treatments are designed to treat the underlying condition.

Christian Martin Itin: or to actually provide treatment until we, I think the opportunity for CARE in that field would be to have an opportunity to get a meaningful response and adjustment of the disease through a single intervention and then actually have, you know, hopefully, you know, a year to several years, maybe longer, where you don't need additional intervention. And I think that is part of the attraction.

Christian Martin Itin: It's also, when you think about it from a cost perspective, the fact that the regiments are given until relapse, I'll say RACC-Sull, a lot of cost over time. And that's, you know, what's driving a lot of the revenue lines that we see in the space. I think also in that context, that's very costly. And if you can actually have a one-time intervention, there are a lot of treatment-related costs that you could obviously take out of the equation.

Christian Martin Itin: So there's also, I think, an interesting economic argument to be made. A very strong one from a patient's perspective of having sort of a single intervention that then actually keeps you in good shape for an extended period of time. as well as, I think, an element of patient management cost that's there. And so when we look at, in terms of the profile for a product, I think you want to have a product that has a product that has the ability to actually have a very good safety profile. It's very well managed.

Christian Martin Itin: But that is combined with an ability to sustain pressure on the lymphoma because that's, in essence, what any other therapy does. It's maintaining pressure on the lymphoma. In order to do that, you also would actually ask the lymphoma, and the CAR-T therapy, to have an extended persistence so that, indeed, you're able to actually put long-term pressure on the lymphoma and sustain that over time to really put the patients into long-term remissions. So I think those are probably the two key characteristics.

Christian Martin Itin: And obviously, it's one of the key features that we're seeing in our program in probably the most challenging disease setting, which is the adult ALL population. And we do see that very nicely, those two features. And that's why we're interested in exploring that, obviously, in the context of the initial experience in the organization. And if I may ask you a related question.

[music].

Gil Joseph Blum: We've been seeing the allogenic space, particularly in LBCL, kind of moving towards multiple doses of the cell or therapeutic, also involving additional chemo. Do you think that this might provide, you know, kind of an opening for an apologist CART therapy with a better safety profile, like, you know, what you had with Otto III? First of all, I think it's a very interesting question.

Christian Martin Itin: And what we're seeing, and, you know, I think Matt asked the question before in a slightly different way, is that we're seeing that the data start to actually come forward in terms of some of the allergenic approaches. And the fact that many of the companies talk about multiple dosings obviously indicates that, you know, while there is activity in order to sort of get a more sustained activity in the OBICL patients, which is really, you need to get, frankly, to a certain level of cures in these patients to make your therapy worthwhile.

Christian Martin Itin: But that may take, you know, a few more steps. And, of course, the more you add in terms of those things and reconditioning and so on and so forth, you add complexity to the therapy. You add complexity from the management perspective, complexity from the treatment group perspective, and you take away differentiation from a frankly a standard chemotherapy antibody drug conjugate antibody type of combination approach that you also are by specific approach that is also active in the space. I think that's one of the sort of key questions will be, you know, what the standalone activity is, and can you really differentiate yourself differentiate yourself away from those approaches from other approaches that are currently being pushed.

Christian Martin Itin: What we do see is that the level of sustained CRs that are seen on the Carty side, the Autologous Carty side, at this point, at least, has not been matched by any other therapeutic modality. And I think that, you know, it certainly creates an opening, and to part of the comment I made before about follicular lymphoma, having a good safety profile will be important in order for patients to really gain access to the system because those patients, as we pointed out many times during the course of the last 24 months or so, tend not to be treated at the academic hospitals in DLBCL. They're actually much further out into the periphery. And with that, you need a product that actually has a good level of safety.

Christian Martin Itin: And those are obviously hallmarks. We're seeing both. We saw with Auto3 and we're now, obviously, exploring with Auto1. Our OB-CL, and I think we're going to get a very good feel for where that's going to go. But certainly there's more complexity in the DODCL space than probably, I think, many folks anticipated earlier. All right, thank you for taking our questions and I congrats on the continued

Gil Joseph Blum: Thanks a lot. I appreciate it, Gil.

Operator: Thank you. I'm showing no further questions at this time. I would now like to turn the conference back over to Christian Eiton.

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Christian Martin Itin: All right, well, thanks everybody for joining us. Much appreciated. It took time today, and we're looking forward to obviously updating you on the Ash meeting and looking forward to an exciting 2022.

Christian Martin Itin: And with that, I'd like to thank you all and look forward to connecting, hopefully, in person, not too far out. Thanks a lot. Bye-bye. This concludes today's conference call. Thank you for participating. You may now disconnect. I'm

Operator: and so on the end up. I don't know.

Operator: I'm gonna thank you, and and and and and and Thank you, and and and and Thank you, and so on. Thank you. Thank you. Thank you. Thank you. Thank you, and Thank you. Thank you. Thank you. Thank you.