Q4 2022 Autolus Therapeutics PLC Earnings Call

March 7, 2023

Speaker 1: The conference will begin shortly. To raise and lower your hand during Q&A, you can dial star 11.

Speaker 2: Oh

Speaker 1: Ladies and gentlemen, and welcome to the Altilas Therapeutics Full Year 2022 Financial Results Conference Call and Fourth Quarter Operational Progress. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Julia Wilson, communications consultant. Please go ahead. Julia Wilson is a master Eighth Curator and her office!? Huge thanks to our host for their leadership!

Speaker 3: Thank you, Norma. Good morning, all good afternoon, everyone, and thank you for joining us to take part in today's call on the full year 2022 financial results and operational highlights for the fourth quarter 2022. I am Julia Wilson, a communications consultant for Auckland. With you today, Dr Christian Eitin, Chief Executive Officer.

Speaker 3: and Dr Lucinda Crabtree, our Chief Financial Officer. Before we begin I would like to remind you that during today's call we will make statements related to our business that are forward-looking under federal securities laws and the safe harbour provisions of the private securities litigation reform act of 1995.

Speaker 3: These may include, but are not limited to, statements regarding the status of clinical trials and development timelines for our product candidates and our expectations regarding our cash runway. These statements are subject to a variety of risks and uncertainties that could cause actual results to differ materially from expectations and reflect our views, only as of today.

Speaker 3: We assume no obligation to update any such forward-looking statements.

Speaker 3: For discussion of the material risks and uncertainties that could affect our actual results, please refer to the risks identified in today's press release and our SEC filings, both available on the investor section of our website. On slide three, you will see the agenda for today, which is as follows. Christian will provide an overview of our operational highlights for the fourth quarter of 2032.

Speaker 3: Lucinda will then discuss the company's full year financial results before Christian will conclude with upcoming milestones and any other concluding comments.

Speaker 3: Finally, we will, of course, welcome your questions. Over to you, Christian.

Speaker 4: Thank you, Julia, and good morning to you all. Thank you for joining us. It's my pleasure to review our progress for the fourth quarter 2022.

Speaker 4: Moving to slide 4, we're really pleased with our program and operational progress during the 4th quarter of 2022, which is highlighted over the next 2 slides. Firstly, we're delighted to announce in December that the pivotal phase 2 Felix clinical study evaluating OB cell in relapsed refractory adult patients met its primary endpoint.

Speaker 4: based on overall response rate in a pre-planned interim analysis of 50 patients with morphological disease and as verified by an independent data monitoring committee.

Speaker 4: We are another step closer to bringing this potentially innovative treatment to an underserved ALL population, and I'll delve into the data in more detail later in this presentation. This positive data triggered a $35 million milestone from our partner Blackstone Life Sciences earlier than anticipated.

Speaker 4: And we're planning to provide a data update on all patients treated by mid this year, most likely at ASCO with longer follow-up plans at the end of 2023, as well as planned CLA submission to the US FDA by the end of the year.

Speaker 4: December was a busy month for us. We also had a number of clinical updates at the American Society of Hematology annual conference, including presenting longer term follow-up data from our adult ALL patients in the old CAR19 phase one study of OB cell showing 35% of patients in ongoing remission.

Speaker 4: at 36 months of follow-up, median follow-up, with no additional anti-leukemia therapy.

Speaker 4: In addition, OVCEL continued to show high levels of clinical activity in relapse, refractory non-Hochkin lymphoma and chronic lymphoplastic leukemia patients paired with a well-manageable safety profile.

Speaker 4: We were also very encouraged with the data we presented from our pediatric ALL program, the CARPAL Phase 1 trial of Auto122, our dual targeting CAR T therapy targeting CD19 and CD22.

Speaker 4: With over 80% of patients achieving a molecular complete remission with no antigen negatively lapses observed.

Speaker 4: Additionally, we provided longer-term follow-up at the Libra T1 phase 1 trial of ORO4 in peripheral T-cell lymphoma with some patients experiencing durable metabolic CRs, including one patient up to the one-year mark post treatment and also in continued remission.

Speaker 4: We will be providing updates on these programs over the course of this year and will also be presenting data from the CARIS-HELL study of OB-CELT in peripheral CNS lymphoma patients, the MCCARTHY Phase 1 trial of Auto8 in multiple myeloma patients, and finally, the Phase 1 trial of Auto6-NG.

Speaker 4: and neuroblastoma patients is expected to start in the next quarter.

Speaker 4: Turning to slide 5, we have made some great operational progress during the quarter.

Speaker 4: Towards the end of the year, we closed a public offering raising aggregate gross proceeds of 164 million and net proceeds after underwriting discounts and offering expenses of 152.4 million, including a partial exercise of the green shoe by the underwriters. With our leave, we are now well positioned financially to bring OV sell and in

Speaker 4: $35 million milestone from our partner, Blackstone Life Sciences, as a result of the positive interim analysis of OB-CEL in adult DLL.

Speaker 4: At the same time, we received an additional $35 million milestone from Blackstone as a result of planned activities supporting the performance and qualification of the OB-SEL manufacturing process.

Speaker 4: You will recall that we signed the agreement with Blackstone at the end of 2021, a part equity and part program financing collaboration for our lead candidate, OBSL, and we have now received 220 million of the total 250 million committed capital.

Speaker 4: We were very pleased to announce three deals, two in October 2022 and one post period end in January 2023, which underscores what we believe is an industry leading cell programming technology platform we have developed at Autolus.

Speaker 4: We signed an agreement with Bristol-Myers Squibb, granting them access to our proprietary RQR8-by-Tuximab-induced safety switch for incorporation into a set of selected cell

Speaker 4: In addition, Moderna exercised an option on one of the proprietary binders being developed against an undisclosed immunoncology target for the delivery of pioneering messenger RNA therapeutics.

Speaker 4: This license option stems from the deal we announced with Moderna in August 2021.

Speaker 4: Finally, in January 2023, we signed an agreement with Cabelletta Bio, which allows them to incorporate the RQRA safety switch into a cell therapy program for the treatment of autoimmune disease. and that that dairy! Yea!

Speaker 4: The total license revenue was 6.2 million in 2022 and each of these deals have the potential for additional revenue in near-term option exercise fees, milestone payments and royalties.

Speaker 4: We continue to make steady progress in our manufacturing and CMC operations. The first phase of the build of our commercial manufacturing facility was completed with the handover of the first of three clean rooms at the end of last year. We have named this facility the nucleus.

Speaker 4: We're now working on the qualification and validation of the nucleus and will remain on track for good manufacturing practice operations commencing in the second half of 2023.

Speaker 4: We're also undertaking the development work and report generation for the CMC package plan to support the BLA submission to the FDA.

Speaker 4: Finally, total cash in cash equivalent and restricted cash at the end of December were 382.8 million dollars.

Speaker 4: With that, let's talk more about OV cell on slide number 7.

Speaker 4: OVCEL has a unique mechanism of action. What's fundamentally different about our product candidate is that it has an ability to engage physiologically with the target cell.

Speaker 4: rapidly binding to the target which delivers specificity, paired with a fast-off rate for rapid disengagement from the target cell once the kill has been delivered.

Speaker 4: This unique engagement drives maximal activity while minimizing toxicity and is at the heart of the differentiated clinical profile we are observing in acute lymphoblastic leukemia, non-Hutchkins lymphoma patients and chronic lymphoblastic leukemia patients.

Speaker 4: Moving on to slide number eight. Our clinical experience with OB cell and ALL shows high overall response rate across all, sorry, population under.

Speaker 4: It shows a high level of clinical activity across all indications. Our clinical experience with OV cell and ALL shows a high overall response rate across all patient populations, including a very high level of clinical activity over the longer to room.

Speaker 4: that we have now observed in the old CAR-19 study. We have a median follow-up of 36 months now in this study and with a follow-up of 24 to 47 months of observation we see that 35% of the patients are in long-term remission after receiving OVYcel and receiving no further anti-leukemia therapy.

Speaker 4: The safety profile is well manageable with low levels of high-grade CRS and ICANs. The midsection of the slide shows the patients with long-term remissions and continued presence of CAR T cells over the entire observation period.

Speaker 4: The program is developed on their ARMAT, Prime and I-Lab designations.

Moving to slide 9, we completed the enrollment and dosing of a pivotal study, a study we call the PELIX study, in adult relapse refractory ALL patients. And as I mentioned, we announced in December that we have had met the primary endpoint of overall response rate in an interim analysis space

based on the first 50 patients followed for at least three months of follow-up.

Clinical benefit in ALL will be assessed based on patients remaining in sustained complete remission.

We conducted this study in 34 centers, 24 centers in the US, 7 centers in the UK, 3 centers in Spain during the peak of the pandemic. It is important to realize that relapsed, refractory adult bailout patients are highly immune suppressed.

and the pandemic poses a significant added risk to them.

Moreover, due to access restrictions and various other pandemic rules and regulations, we could not access our clinical trial sites for the most part of the Felix study.

You can imagine end-stage ALL patients are about as difficult a patient population to work with, particularly in an environment where there is a high risk of infection. And indeed, we did lose patients to COVID.

In many ways, this study was more of a real world study conducted under difficult circumstances.

In addition to patient safety, every aspect of product delivery in logistics or pressure tested during this trial, with massively reduced air traffic and impact of the pandemic except developers manufacturing teams nigh testing.

Remarkably, manufacturing for all patients from our facility in the UK turned out to be an asset also for US delivery, as the long-haul flights between the US to the UK had priority over US and also EU domestic flights.

Next, key data readout is planned for ASCO in June this year. Moving to slide number 10. This slide summarizes the announcement we made in December regarding the pre-specified interim analysis of the first 50 out of 90 patients dosed that had reached at least three months of follow-up. The primary endpoint is based on overall remission rate, which includes patient's blood pressure,

Safety analysis was conducted on a larger 92 patient data set and showed an excellent profile with high grade cytokine release experienced in less than 3% of patients and high grade ICANN's or neuro toxicity in less than 8% of patients.

ICANs were fully reversible and less than 25% of patients had any grade of neurotoxicity.

In contrast to approve T cell or T cell engaging therapies, a very unusual safety profile in this population.

As I mentioned earlier, this exciting data set triggered a $35 million milestone from Blackstone.

Moving to slide number 11. This slide summarized our current experience with OB-Cell across ALL.

As you can see, the data are highly consistent across the various studies, both in safety and efficacy.

Worth noting is that the CAR-PAL and All-Carr 19 study were conducted prior to the pandemic, while both parts of the FELIX study were conducted during the pandemic.

Both the car panel and old car 19 study were conducted in the U.K. While the Felix study was largely conducted in the U.S.

What we did pick up is that the patients of the Felix study were more advanced in their disease based on Bertuma Burton and increased presence of so-called extra-modelary disease.

This is in essence a gain of function of the leukemia that allows it to leave the bone marrow and successfully settle and grow in other organs.

Patients with extramedology disease respond poorly to any type of antilocene therapy.

Moving to slide 12 to look further into the data we presented at ASH from the old CAR19 study.

When we then look into the outcome or long-term observation from the old car 19 study, we're up to obviously with four years of follow-up and you can see that we have a quite unusual clinical profile.

When you look at the swim plot and moving from the bottom up, we adopted some patients that did not respond to therapy.

Then we have some patients that respond to the relapse quickly. The yellow circles are patients that relapse with so-called CD19 negative disease.

In essence, the leukemia became invisible to the therapy, by losing the very structure the therapy was designed to recognize.

If you then go a little further up, you see three red circles. There is a patient that relapsed because the CAR T cells, the OV cell product candidate, didn't persist long enough and patients relapsed with CD19 positive disease.

Above those, you then see a group of patients that are in long-term remission between two and four years without any additional therapy.

Seven out of the 20 patients are 35 percent.

are in continued remission without receiving any additional antilequemia therapy with median fall off of 36 months in the range of 20.

forty-seven months.

Every single one of these patients has persisting CAR T cells.

You see one additional patient with long-term remission who received a stem cell transplant while in complete remission.

Moving to slide 13.

But inside though, a T-cell engaging CD19 targeting monoclonal by specific antibody has become the standard of care in relapse refractory adult LL with the last few years.

Key to its success has been the well-manageable safety profile. Key focus from a patient management perspective is the monitoring of neurotoxicity or ICANNs, which impact 65% of patients treated with bonsai.

In contrast, OB-cell had less than 25% of patients' experience eyecans of any grade.

High-grate CRS for pleinsito is low with about 5% and OB cell seems to be similar and potentially slightly better in terms of high-grate CRS.

In contrast to glencyte-dotecardus, a CAR-T program approved for this indication induces a high grade, induces high grade cytokine release syndrome in 26% of patients and high grade neurotoxicity in 35% of patients while 87% experience neurotoxicity of any grade.

40% of patients received raise of pressors.

Managing such a safety profile often requires access to ICUs. Finally, in a two-term app, while active, is primarily used as a bridging therapy.

Moving to slide 14.

The market opportunity in the blaster factory ALL is in fact unchanged with about 3,000 patients in high need for therapy between the US, Europe and Japan. Moving to slide 15, Linsito, the standard of care in the blaster factory ALL.

has reached sales in 2022 of 583 million with a year-over-year growth of 24%. This product is commercialized by Amgen.

Currently, the product reaches about 2,000 plus adult patients with ALL, an average on average receiving two cycles of glencyto.

Patients with low disease burden can receive up to four cycles of blingcytope.

at a combined cost comparable to CAR-T therapy. Key to Plains Island's market penetration is its well-manageable safety profile, which allows delivery non-academic hospitals in addition to the academic centers.

We believe that OVSEL with a high level of clinical activity, attractive safety profile, and one-time administration is well positioned to capture that opportunity.

When we look overall in terms of the price level for CAR T therapies in ALL, they are in the range of $450,000 in the US.

Moving to slide 16. When we look at the steps forward, first of all, we're planning to disclose the Felix data from all patients stoced in the mid-2023, likely at ASCO and also at EHA.

Moving to slide 16. When we look at the steps forward, first of all, we're planning to disclose the Felix data from old patients' stoves in the mid-2023 likely at ASCO and old SODHA. Long term follow-up is plan for ash.

We're targeting the BLAs admission for the program towards the end of the year, MA filing towards the end of the first quarter 2024, and the UK filing in the second quarter of 2024.

That sets us up very nicely for the key territories that we expect to be initially active in. In addition to the mature clinical data, the submission will also require data from the validation of our commercial manufacturing site.

This work has been a key focus throughout the first half of 2023 and will continue into the third quarter. Importantly, our commercial manufacturing facility is set up to cover supply for approximately two-thirds of the estimated market from the start.

As we're moving through 2023, we need to prepare three key areas for commercialization. First, creating awareness for the program through a focused medical affairs program.

Second, establish the value proposition for payers in our HTA dose series. And finally, third, prepare for and start center onboarding, a process that will take between nine and 15 months to get each center ready to deliver CAR T therapy.

Moving to slide 18, to talk about the broader opportunity that we see with OB-CEL.

As part of the old car 19 Extension study we have been evaluating OB cell and relapster fracturing on Hodgonsland phoma, acronicallymphoplastic leukemia patients. We see consistently very high response rates combined with a very attractive safety profile suitable for our patient use. The data will form the basis for the selection of a second indication.

Building an OV cell, we're adding a highly potent CD22 corridor that can recognize very low amounts of CD22 on the surface of leukemia cells.

This program was initially evaluated in children who have failed Kim Raya, or were not eligible for Kim Raya therapy.

In this very challenging patient population, we saw an 83% molecular response rate and none of the children relapsed with de novo CD19 negative disease.

Comparing this activity to OB cell we would have expected a molecular CR rate of approximately 40 maybe 50 percent.

We're working on further streamlining the manufacturing process for Auto 1.22.

knowing that we have an attractive life cycle option. Timing of investment decisions in order 122 will be balanced with additional indication investments for OVCEL.

attractive lifecycle option. Timing of investment decisions in Order 122 will be balanced with additional indication investments for OB-CELF. Slide 19.

Switching gears, moving on, switching gears to slide 20 as well as 21. Our technology platform allows us to engineer a range of properties into T-cells to drive specificity of recognition, resilience against negative signals used by tumor cells to evade T-cell attack, and providing survival signals for T-cells. Our strength in T-cell engineering drives our pipeline.

and is also at the heart of the three collaborations reported on in 2022 and early 2023 with Moderna, BMS and Kavaleta.

On slide 22, we have a quick summary of the earlier stage programs in T cell and phoma with auto 4.5, auto 6.ng in neuroblastoma, and auto 8 in multiple myeloma. Both auto 4 and auto 8 are in phase 1 clinical studies, and auto 6.ng is expected to start phase 1 in the next quarter.

On slide 22, we have a quick summary of the earlier stage programs in T-cell lymphoma with Auto IV-V, Auto VI-NG in neuroblastoma, and Auto VIII in multiple myeloma. Both Auto IV and Auto VIII are in Phase I clinical studies, and Auto VI-NG is expected to start Phase I in the next quarter. Moving to slide 23.

C-cell lymphoma has a very high medical need, quite similar to BALL. In fact, when you look at the NCCN guidelines, it is where it basically says that once you're through the frontline therapy and fail, you have to go on a clinical trial.

Moving to slide 24.

With its unique targeting approach, Auto4 starts to show meaningful clinical impact at the higher dose levels that we have evaluated.

The first metabolic CRs are reaching one year post-streatment and we continue to follow those patients.

In addition, we have streamlined the manufacturing process and are exploring the activity in an additional cohort and we're planning to report on that outcome later in 2023. Moving to slide 26 to talk about manufacturing. Cell manufacturing is at the core of any autologous self therapy.

and it is important to be able to do that to have a successful role of all of your therapy. Building on the robust and well-correct-righted process used to manufacture the Felix clinical study, we're standing up our commercial cell manufacturing facility called the Nucleus about a mile away from the clinical trial manufacturing site we had used for the study. This proximity is important as we'll be able to move our entire staff to the new facility

And in fact, many of them are already in the process of validating the nucleus facility.

The capacity of the nucleus in its initial setup is 2,000 batches per year, or about two-thirds of the adult ALL market size in terms of capacity.

The new Cliffs has been a fantastic project to realize with an innovative design and about 75% off-site building to accelerate the build while maximizing the quality of the build.

So with that, I would like to turn to slide 28 and pass the call over to Lucinda for our fiscal year 2022 financial update. Lucy?

Thanks Christian. Good morning or good afternoon to everyone. It's my pleasure to review our financial results for the fiscal year to December 31st 2020.

Good morning or good afternoon to everyone. It's my pleasure to review our financial results for the fiscal year to 31st December 2022.

Cash and cash equivalents and restricted cash at December 31, 2022 totals $382.8 million as compared to $310.7 million at December 31, 2021.

Next, total operating expenses for the 12 months ended December 1, 2022 or $168 million. Netsov Grant income and licence revenue of $6.4 million. As compared to total operating expenses of $165 million, netsov Grant income and licence revenue of $2.3 million.

year ended December 31, 2021. This was primarily due to the following. An increase of $11.6 million in clinical costs and manufacturing costs primarily relating to our O2C critical product candidates. An increase of $0.4 million in legal fees and professional consulting fees in relation to our R&D activities. An increase of $0.3 million in O2C critical products candidates.

An increase of $0.2 million related information technology infrastructure and support for information systems related to the contacts of clinical trials and manufacturing operations. An increase of $0.2 million in cell logistics costs. An increase of $3.7 million in the services costs related to determination and closure of our U.S. manufacturing facility in 2021 and shifting our overall manufacturing strategy.

a decrease of $0.9 million in depreciation and amortization related to property and equipment and intangible assets, and finally a decrease of $0.6 million in salaries and other employment costs, including share-based compensation expenses, mainly due to lower exchange rates used upon consolidation for the year ended December 31, 2022 compared to the year ended 31, 2021.

and this is offset by an increase in employees engaged in RID activities. General and administrative expenses remain consistent at $31.9 million to the year end of December 31, 2022 and 2021.

respectively, primarily due to the following, an increase of $1.4 million in salaries and other employment costs, including share-based compensation expenses, mainly driven by an increase in the average number of employees engaged and junior activities. An increase of $0.3 million, primarily related to information technology costs.

and that increase of $1 million in legal fees and professional consulting fees and relation to our GNA activities, which will offset against lower D&O insurance, director and officer insurance. A decrease of $1 million of commercial preparation costs due to the timing of related activities. A decrease of $0.4 million in facilities costs related to determination of certain lease agreements in the past year.

and decrease of $.4 million in depreciation and amortization related to property and equipment and in tangible assets. Interesting come increased to $1.7 million for the year ended December 31st 2022 compared to $0.3 million for the year ended December 31st 2021.

The increase in interest income of $1.4 million per memory relates to the increase in interest rates on our interest bearing bank accounts and short term investments during the year ended December 31, 2022 compared to 2021.

Interest expense increased to $8.9 million for the year ended December 31, 2022, compared to interest expense of $1.1 million for the year ended December 31, 2021. Interest expense is primarily related to the liabilities of future royalties and salesmills, milestones, which arose upon the execution of our strategic collaboration and financing agreement with Blackstone in November 2021.

The increase in interest expense for the year ended December 31st 2022 is primarily driven by the full year of the liability related to the Blackstone collaboration in 2022 compared to a partial year liability accrued in 2021.

Other income or expense increase to an income of $2 million for the year ended December 31st 2022 from an expense of $1 million for the year ended December 31st 2021. During the year ended December 31st 2022 we recognized a foreign exchange gain of $1.7 million.

a sublease income of 0.2 million dollars another income of 0.1 million dollars. This compares to an expense of 0.1 million dollars as I mentioned for the year ended December 31st 2021 which included a foreign exchange loss of 2.2 million dollars offset by a gain on lease terminations of 2 million dollars another income of 0.1 million dollars. Income tax benefit increased to 24.4 million dollars for the year ended

December 31, 2022 and this compares to $142.1 million for the same period in 2021.

The basic and diluted net loss for ordinary share for the 12 months ended the December 31, 2022, totaled $1.57. Compared to a basic and diluted net loss, the total net share of $1.97 for the 12 months ended December 31, 2021.

Finally, autonomous estimates that its current cash and cash equivalents on hand and anticipated project financing payments from Blackstone will extend the company's runway into 2025. And now back to Christians to give you a brief outlook on expected milestones. Christian. Thanks Lucy. Moving to slide 30.

Finally, we think we have an exciting year ahead of us. Key focus is on getting OB-SEL into the regulatory process with BLA filing targeted towards standard year, followed by filings in Europe in the first half of next year. Next up are the Plan Felix Data Presentations mid-year 2023.

In addition, we're preparing for commercial product supply and launch readiness. Finally, we also expect to provide updates on the pipeline program with additional data and follow up during the year. And with our key programs unpartnered at this stage, we have opportunity for setting up collaborations. Moving to slide 31.

So with that, we believe we're at an interesting point with the company. We've got the cash to deliver a very significant value step. We've got the data to show that with OB cell behalf of differentiated product profile that addresses the high medical need with limited competition and with possibly a transformational outcome.

Alongside that, we have additional opportunities for OVCEL in broader indications and a valuable pipeline of other oncology programs. As I mentioned, we're excited about our manufacturing facilities and what facility and we have a strong technology foundation, validated by our collaborators, the MS, Moderna, and the W?CEL, mind of

and we look to do more details of that nature in the future. With that, thank you very much and we're happy to take questions.

to do more devils of that nature in the future. With that, thank you very much, and we're happy to take questions.

Thank you. To ask a question you'll need to press star 11 on your telephone. To withdraw your question please press star 11 again. Please wait for your name to be announced.

Please stand by while we compile the Q&A roster. We will take one moment for our first question.

Our first question comes from the line of Gil Bloom with Needham and Company. Your line is now open.

Good morning and good afternoon and thanks for taking our questions. Just the 1st, 1 on the data that was published from the study. So, there appear to be a slightly higher incidence of grades 3 and kind of earlier studies. Given that all of those goals to have oversell administered in the community setting.

How do you think physicians will adjust to levels of high-grade AEs? Gil, first of all, thanks a lot for joining. Really good question. So I think it's important when we put the data in perspective. What we did show is that we have less than 3% high-grade CRS and we have less than 8% ICANs.

This is a level of grade three events in both types of adverse events that is at or below the level of purpline cytos, which is currently used in non-academic centers. And so we believe that actually the profile is very well suited and matches the experience actually already established with the standard of care in those centers.

data by the filing data, including OR and duration of response. But will you also be including data from your MRD positive cohort? So, really good question. So first of all, in terms of our demonstrated clinical benefit in the more biological core, which are patients that have...

more than 5% disease burden at the time of inclusion into the study. The focus is to demonstrate that he can actually convert these patients into complete formations that are sustained over time. So what you will have to look at is CRs with a minimal level of follow-up.

Second, of course, the safety profile was then a key part of the assessment to understand actually the benefit-risk ratio that you have with the product, which is obviously a very key parameter to understand the suitability of a product in any given indication.

In with regards to the focus when you think about the review, it really will be focused initially on the patients that have morphological disease. We obviously have also assessed mineral residual disease in these patients, the level of MRT signals that we have in the...

that also patients with minimal residual disease is a data set that OC is being generated, but it is also a data set that is not going to be part of the initial filing.

in terms of it will go into safety but it is not an aspect of the efficacy evaluation for the initial filing that we're planning.

Give it a clarification. And last one for Moss, you did mention that from your scientific collaborator, there may be some data on multiple myeloma. What do you think the gating sector would be for further development of that program given and how crowded the market is? Thank you.

Yeah, very good question. So what you're referring to is the auto-8 program that we're working on with our colleagues on the academic side. We're currently running a phase one clinical trial to evaluate the activity of auto-8 in relapse refractory, multi-myloma patient.

I think we're in an interesting spot with regards to the Cartesian model myeloma. We have obviously seen very nice levels of activity with the two approved products in the space, but there is also a very high unmet need and at this point still a remarkable inability to meet the demand.

molecular remissions. And at the same time, also we're looking at the safety profile. We clearly wanna see in a very significant level of clinical activity in these patients, to as a basis, to consider taking the program forward. And if we're at that point, you know, clearly would anticipate that this would make sense to do in a partnership. BPC Center for speaking with

Okay. Thank you, Gil. Thank you. One moment for our next question.

Our next question comes from the line of Mara Goldstein with Miss Zuho Group. Your line is open. Great. Thanks so much for taking the question. First of all, on the multiple myeloma data that you do anticipate having this year, can you just give us some element of just the scope of that number of patients and what exactly we should be prepared to be looking at? And then I also wanted to ask on Obacel and.

is a small phase long clinical study so we're looking at around 10 patients as sort of the initial experience and then we'll take it from there. So it's gonna be an initial look at that at the profile of the product in that initial set of patients. Now with regards to OV cell.

What we're expecting to go for is obviously a positioning of the product in the relapse refractory setting whether patients have had already received Plinsidone or are post-plinsidone

And I think that is sort of obviously what the current study actually is evaluating its patients that have, are in very advanced disease and with a portion having have blincyto in a toosamap or an apportion who didn't. So you're looking to position the product both in parallel or after blincyto therapy.

Obviously, the tachartis is obviously positioned in that exact same way, so it would be the same type of positioning that we would expect for the program. Okay, thank you. Thanks, Mara. Thank you. We'll go to the next question.

And next question comes from the line of Matthew Fitz with William Blair. Your line is now open.

Thank you. Thank you for taking my question. At the recent European CAR team meeting, Kites were really represented the long-term follow-up from June 3 with the CARTIS. And it shows very few patients, really remaining in CRM beyond two years. And so it's pretty big contrast to the day you presented it from follow-up with the COVID-19.

which is 35, 40% of patients don't see our three years. So do you expect the field state to recapitulate the all-car-19 durability given? You've talked about a little bit tougher to treat patient populations with extra modular disease and such. And I guess just how do you kind of get that durability message across to physicians?

in your kind of education process. So really good question. Thanks for joining us. It's really what you're pointing to is really kind of the, I think what we believe was really remarkable data from our initial evaluation of OB-cell in this patient group. And obviously as you pointed out what we did see is a

stabilization of our long-term durability curves, et cetera, with patients saying in sustained remissions about, as it pointed out, by 35% of the patients being in that category. So that is a remarkable outcome. It's clearly something that has not been possible when I developed with my old team, Glenn Saito and has not been shown clearly, not being shown with the cargaz either. So what we're looking, what we're expecting to see with OVCELLs and the Phelic studies that we also see a similar shape of the curve.

where exactly that stabilization will ultimately occur. I think that's too early to tell. We don't have enough follow-up in the study at this point in time. But that is what we're looking for, and that's what we expect to see. Whether it's going to be the exact same level or slightly different level, we do not know at this point in time. And as it pointed out, obviously, one of the things that we do have.

had in terms of inclusion into the studies, obviously patients that certainly in that, you know, initial data set that we presented that had, you know, pretty significant levels of disease burden as well as extramed all the disease, which frankly was not too much as the price given that that first 50 patient data set really was truly deep pandemic.

And so, you know, we'll see, obviously what the full data set looks like, but, you know, we're obviously expecting to see the same shape of the curve, and at this point in time, we can't exactly say where that's actually going to come out, that requires long-term follow-up. The fact that we saw the persistent state attract what we had seen before.

I think is very encouraging because obviously that was a clear correlation that we did see that all these stations that had long-term outcomes also had long-term persistent car T cells. And the shape when you look at the persistence coming out from the child as we had indicated from the intraminalysis was tracking the old car persistence curve. So that is encouraging. I think it's a valid indicator.

but obviously requires long follow-up to sort of be clear about where exactly we might be landing. Okay, can I ask what point do you request a pre-BLA meeting this year? Is that something you do after kind of the ESCO update? So it's really a good question. So I think what you want to do at the time you go for a pre-BLA meeting is

You want to actually have the data with sufficient level of follow-up. So you have a very clear positioning around the outcome that you can actually present and discuss with the agency. And obviously the data we're going to go with into ASCII, I think we'll start to give us, I think, a good level of observation. So we would expect that this is going to be an interaction post-ASCO. Okay, great, thanks, Christian. Okay, thanks a lot, Matt.

Thank you. One moment for our next question. Our next question comes from Kelly Shih with Jefferies. Your line is now open. Congrats on the progress and thank you for taking my question. Regarding the baseline for patients enrolled in the SOLIX trials, does it appear consistent with place 1B cohort under a fraction of patients? Yes, it is consistent with place 1B cohort under a fraction of patients.

Thank you for joining Kelly. Nice to have you on the call. First of all, in terms of the patient population, overall, after the patient population is close and very close to what we've been seeing in the Phase I portion of the study. And what we expect to, what we also expect to see is obviously some variability as we're sort of going through the peak pandemic into study as well. So we're close. You know, we may actually have seen even a bit of a worsening after that.

going to the appropriate level of perspective as well.

So that's sort of the answer to the first question. What was the second question?

Thank you, super helpful. So my second question is, given the differentiated profile, especially on 50-strands of Auto1, will consider exploring the opportunity in auto-email indication such as loopers, given that some proof of the concept data has been available? Thanks.

Thanks. Thanks for the question. Well, what you're pointing to is a really remarkable data set that was developed by Andreas Markinson and his TD, the University of Air London, who've done a fantastic job evaluating the utility of the CD-19 CAR T approach and patients.

with refractory systemic lupus. The outcome of the data was quite remarkable. It's an age of medicine paper at the end of the month published at the end of last year. We know the team actually had also worked with the team at the early stages and decided to develop them way back almost 20 years back.

Really good data set. We believe obviously that, you know, OB-CEL has a remarkable profile of us and I was a lot of data around. The safety of the program is clearly has an absolute outstanding safety profile, which is important when you think about using autoimmune disease. And the other aspect of course is that as we all learned in this space.

initial application in ALL. So absolutely, we're following that field very closely. We think it is a very attractive potential future use of programs that are very safe and very active and will leave over the self-fit staff very well.

Thank you. Any other next question comes from the line of James Shin with Wells Fargo. Your line is open.

Good morning and afternoon guys. Just a couple from RN. I just want to dig a little deeper into the positioning of OBSEL. So do you envision OBSEL could be positioned ahead of Blinside to that some point? And is there a future study exploring this? And then on a related matter, I mean, self therapy as a whole has started to make good headway to the earlier with a couple oncologists. See if there's some regulatory hurdles.

namely the FACT immune effector cell accreditation that makes cell therapy entering the community setting a little bit.

difficult or intensive. Any thoughts there? Really appreciate it. Yeah, well first of all, thanks for joining, James, and I think a very interesting question. So first of all, in terms of sequencing, at this point in time, obviously.

Plentite is approved both in the relapsing refractory setting as well as in patients that have mineral residual disease and that are basically in CR1 or later. So in essence it's patients that have gone through frontline therapy with still remaining residual disease other than technically.

from the Dicartis approval is that the Dicartis was approved for relapse refractory patients without actually defining, you know, it's the second, the third line or fourth line. Actually, it's any relapse refractory setting.

And so we would expect that the OPPI cell will have the same type of scope initially. And obviously with the work we do on minimal residual disease and evaluating the activity of the program there, I think should allow us to eventually position the program similar to the way that the...

of the academic centers considering that you need the level of training or accreditation of those centers to be able to actually deliver the product. Now I think what we need to understand is that particularly with OV cell, we do obviously have a very, very similar profile to link sites on impacted patients with...

Low disease burden illness that we do have an even better profile that we've shown in these end stage, high tumor vermin patients that we also recorded in our interim analysis.

So, when you look at that population that has low particular lower disease burden, but even the one that we have treated now.

The adverse event profile that we have in these patients is exactly what the physicians today do manage with Glint-Cyto. The same level of higher grade CRS, in fact it's a little less than what Glint-Cyto has and it's actually less neurotoxicity than what you see with Glint-Cyto.

What's very important in that context is that obviously when you look at the overall level of neurodoxicity, it's in about two thirds of the patients have any half some level of neurodoxicity with plain cytos, which requires you to monitor the patients, to observe them and make sure that you stay at the top of it.

What we have with OVY cell in a more advanced patient population, because obviously we include glencytophalures in the FELIX study, we actually have a little more than 20% of patients that have some form of neurotoxicity, so it's actually substantially less. So the actual monitoring level is less than BIRM that we have, and with that we believe there's an opportunity.

To actually manage this and with the experience on the inside that should be able to manage this in non-academic hospitals and associated potentially outpatient settings stand-alone So that is sort of where that is now in terms of the ability to deliver CAR T therapy there's obviously a level of Not only patient management that's required which is covered very well with the experience on the inside

But it is also obviously required to actually handle the cells and manage the cells as part of the therapeutic approach and that requires a level of training that obviously needs to be put in place. And we believe that that is a possibility for non-academic hospitals. And then we have to see how further, how further out you might actually be able to go. But I think this gives you a very good penetration.

and ability to reach the ALL population with this profile, as we see and basically demonstrated through the insights already. Thank you. Can we now move to the next slide?

One moment. And our next question comes from the line of Sebastian Zandiskou with Van Nen Scott's Chimper. The line is open.

Hi, good morning and good afternoon, I'm the best in the squad from the Dutchhold Camping, but I'm very, congrats on the project. I was just wondering at the

for the opportunity of all be selling other indications beyond the AOL. Will there be an additional updates on the Alcar study for the for the other indications with additional patients and are there any of these indicators that you believe would allow for an accelerated approval pathway after additional data can show the same level of efficacy

for in to adopt amateur metric indications. Thank you.

Thanks for joining. So when we look at the opportunity that we see with OVSEL, other things, what the product is, you know, has a remarkable profile in these two, basically, removes the B-cell compartment, shows on malignant cells as well as healthy cells, and do that with a very good safety profile. So that's the basic property of the product.

Where that is suitable, obviously, is in leukemia. It is in non-hushed insulin phoma, which is what we're evaluating and CLL, what we're evaluating as part of the old car 19 study. And then as Kelly was pointing out, there's also certain applications in the auto-mute space.

where that might become quite interesting and some delete data would indicate that you might even be transformational in those settings. So this is sort of the range I think you have in terms of opportunity. It has been well on the oncology side but also one that starts to build up also in the open view side. So that's the range. And now the question of choice.

What we're seeing in our old CAR 19 study is that we're having a very high level of clinical activity across the entire range of these indications. The fact is that there is also a lot of confidence in terms of the overall property of the car.

In terms of the individual indications, obviously, you have opportunities looking at the LDTL as an example where we see very high level of different plate formations that are sustained. We haven't seen any real access today in that cohort, which is quite remarkable. We have seen a very high level of different plate formations that are sustained.

There are also very interesting data in mantle tail, as well as sea level that we have seen. Now all those indications are opportunities to develop in segments of the indications.

which allows you to move relatively quickly and with accelerated path. And then depending on the indication you look at, you also made an interval to attitudes that would go for a last-line fitting. We'll actually start looking at an earlier line, a study as well, which would be a randomized control study in that earlier line.

I wouldn't want to move on that reasonably, in a reasonable sort of time relation to your last line setting. So that's sort of the opportunity and we're looking at these and also the data from the old car data. The old car study does give us a very nice basis to do.

develop the right options for the investment. You then also asked about how in that conversation how all the 122 things, and as we indicated, we also do know now that with all the 122 that we have a very active program it appears to do exactly what we want in terms of avoiding the occurrence.

of target negatively laxas, which is the key thing that I'll see if you can be looking to address. And where we know that is particularly important is almost been a few leukemia. There have been initially reports that there is a certain proportion of patients that do actually show CDNK negatively laxas in the context of the food. I just did not want to use my eye to block the disease.

There haven't been as many reports more recently. In our own hands, in widow decay, we haven't seen a TD-19 negative relapse, it's nor did we with our own product program. So, all of three. So, whether or not that is a major issue to actually address in those indications, I think these are clear at this point at the time. And I think that is one of the questions I think will be in terms of the ability to broaden.

the utility of the dual-partnering approach into initial indications. But where it's very clear is that at the NALL, that is certainly a driver for relapse, both for children as well as for adult patients. And we believe at some point it makes sense to consider that program to move into this extension of a B-cell in the acute leukemia setting as well.

So that sort of, I think, is terms of the range as well as the labor-tickling of our ideas. And ultimately, it's a, these are set of investment decisions and it's this question sequencing those investments. And I think the priority will first be on actually broadening the opportunity for OV cell and then in a second step actually then moving forward with OV1, 22 in terms of the actual life cycle, if you're over-sell. Great. Thank you very much.

So that sort of, I think, is terms of the range as well as the way we're thinking about it. And ultimately, it's a, these are set of investment decisions and it's this question sequencing those investments. And I think the priority will first be on actually broadening the opportunity for OV cell and then in a second step actually moving forward with the whole month, but he too in terms of the actual life cycle. Great, thank you very much. Thanks a lot.

Thank you. One moment. And one moment, our last question comes from Africa. I'm going to awarding with Truj Shilane's open. Hi, this is Karina for Austria. Just have a few questions on pricing. With the silent deal by Euro and how are you guys thinking? Too price, I'll be selling. And can you also discuss some preliminary feedback here? Can I ask you a few compare in the US and Europe ?

And also, is there any potential for your pricing power change with detailed data at ASCO? Thank you. I didn't – sorry, Karina, I didn't get the last part of the question. Is there pricing power with the next update at ASCO?

Oh, I see. Okay. Thank you. Well, first of all, thanks for joining. Karina, interesting question for ladies to pricing. I think what we've been seeing in both the state is to the two dimensions. First of all, we're having in-anl specifically also with Linsite though and the use of Linsite though in patients with the lower the deep spurt and we also do this thingy.

use of up to four cycles in those patients, which is basically getting the price for that product into the range of between $4 and $5 a ton of Amazon dollars per patient in the U.S. So that's sort of one benchmark which is standard of care and kind of what bracket that is.

When you then look on the approved CAR key therapy in AMO, that is in the range of four and 50 times during the course of the year. So that's sort of the second sort of, I think, a bracket that we're seeing in the US. And we would expect that we would be pricing in a similar range, obviously, we would believe that we do have...

The product that actually allows you to be more efficient from a cost perspective, because the product should induce flexibility with higher-less patient management, with that I think there should be a good healthy, economic argument supporting the use of OB-STEL, innovation to obviously its clinical process.

With the arts to Europe , where all this scene across the board with Turkey therapy, the prices are starting in the range of where the US prices are with some level of risk and depending on the jurisdiction to look at and the indication.

that the products are delivering. So now this is more variable, and we'll see how that goes. So over the outcome period of time.

And so we'll keep you updated how that field evolves over time but I think this is where we stand and the current expectations is that we would consider to be somewhere in line with what we've been seeing in the space. In terms of data flow I think we're going to have a very interesting data flow as we go through this year. I see at ASCO obviously data from all the patients that were dosed but also still a limited follow-up on some of the patients. I think it's so good for the love of it.

descriptions of the patients, the basic activity, the behaviour of the product in every aspect. And then I think as we go to ASH and then even later into 24, I think obviously much more longer term follow-up, which will flow obviously as an important parameter into the HTA assessments and value assessments that will be conducted by the payers.

So that's got to think where we are with the help that those two take the questions. So just do you think the longer term follow up is going to push pricing higher? Well, first of all, what is the impact of the longer term follow up and showing an impact on longer term follow up? I think is obviously strengthening your value argument over for the product. So I think it will it will clearly make a very strong case for using the product.

Thank you. At this time, I'd like to turn the call back over to Mr. Christian Eaton for closing remarks. Well, first of all, thanks everybody for joining. Obviously it was great to be able to update you on a very exciting fourth quarter that we're running through. I think a very important stretch as we go to the course of this year. Again, the product ready for filings. And I think I would say a real opportunity for...

substantive data updates as we go through the course of the year with the next long-distance expected for the major section. So really looking forward to meeting you hopefully in person, and updating you on the program along those venues and the original successful first half of the year. Here are the...

I think for all of us, I think a more relaxed second half of the year, with some hope that some of the big picture items hopefully will start to turn into a more favorable environment. So with that, I'd like to thank you all and wish you a good day. Ladies and gentlemen, thank you for your participation.

The conference will begin shortly. To raise and lower your hand during Q&A, you can dial star 1 1.

I have you.

and gentlemen and welcome to the Alpolis Fair Pudix full year 2022 financial results conference call and fourth quarter operational progress. As a reminder, this conference has been recorded. I would now like to turn the conference over to your host, Julia Wilson, communications consultant. Please go ahead.

Thank you, Norma. Good morning, all good afternoon, everyone, and thank you for joining us to take part in today's call on the full year 2022 financial results and operational highlights for the fourth quarter 2022. I am Julia Wilson, a communications consultant for Autolus, with me today, Dr Christian Eitin, or Chief Executive Officer, and Dr Lucinda Crabtree, or Chief Financial Officer.

Before we begin, I would like to remind you that during today's call we will make statements related to our business that are forward looking under federal security's laws and the safe part of provisions of the private security solicitation reform act of 1995. These may include, but are not limited to, statements regarding the status of clinical trials and development timelines for our product candidates and our expectations regarding our cash runway.

These statements are subject to a variety of riskful uncertainties that could cause actual results to differ materially from expectations and results of views only as of today. We have seen no obligation to update any such board looking statement. For discussion of the material, riskful uncertainties that could affect our actual results, please refer to the risk for identifying in-state press release and our SEC filing, both available on the best section of our website. On slide three, you will see the agenda for today, which is a follow. Christian will provide an overview of our operational highlights for the fourth quarter.

of 2022, which is highlighted over the next two slides. Firstly, we're delighted to announce in December that the pivotal phase two Felix clinical study evaluating OB cell in relapsed refractory adult-ale patients met its primary endpoint based on overall response rate in a pre-planned entry analysis of 50 patients.

with morphological disease and is verified by an independent data monitoring committee. We are another step closer to bringing this potentially innovative treatment to an underserved ALL population and I'll delve into the data in more detail later in this presentation. This positive data triggered a $35 million milestone from our partner Blackstone Life Sciences earlier than anticipated.

And we're planning to be writing a data update on old patients treated by mid this year. Most likely at ASCO with longer follow-up plans at the end of 2023, as well as plan DLA's admission to the US FDA by the end of the year. December was a busy month for us. We also had a number of clinical updates at the American Society of Humanitology and World Conference, including presenting longer term follow-up data from our adult ALL patients in the old car in 19.

We were also very encouraged with the data we presented from our pediatric ALL program, the CARPAL Phase 1 trial of Auto 122, our dual-targeting CAR T therapy targeting CD19 and CD22. We were very impressed with the data we presented from our pediatric ALL program, the CAR T therapy targeting CD19 and CD22.

With over 80% of patients achieving a molecular complete remission with no antigen negatively lapses observed. Additionally, we've provided longer term follow-up at the Libra T1 phase 1 trial of ORO4, in peripheral T-cell lymphoma.

With some patients experiencing durable metabolic CRs, including one patient up to the one-year mark post treatment, and I was the inconvenient remission. We will be providing updates on these programs over the course of this year, and we'll also be presenting data from the Carousel study of OB-CELD in peripheral CNESL and phoma patients, the McCarthy Phase 1 trial of auto-Aid in multiple myeloma patients.

And finally, the phase 1 trial of autosyxengy in neuroblastoma patients is expected to start in the next quarter. Turning to slide 5, we've made some great operational progress during the quarter. Towards the end of the year, we closed the public offering, raising aggregate gross proceeds of 164 million and net proceeds after underwriting discounts and offering expenses of 152.4 million, including a partial exercise of the grade shoe by the underwriters.

We believe we are now well positioned financially to bring OVCEL and innovative and potentially transformative treatments to an underserved adult day-to-day-little patient population. In 2023, we will be fully focused on submitting a BLA application at the end of the year and working towards commercial launch in 2024.

As I mentioned earlier, we also received a $35 million milestone from our partner Blackstone Life Sciences as a result of the positive inter-analysis of OVCEL in adult 21 trials.

At the same time, we received an additional $35 million milestone from Blackstone as a result of planned activity supporting the performance and qualification of OVCEL of the OVCEL manufacturing process. You will recall that we signed the agreement with Blackstone at the end of 2021, a part equity and part program financing collaboration for our lead candidate, OVCEL.

we have developed at Autolis.

We find an agreement with Bristol Myers Quip granting them access to our proprietary RTR-8 by Tuxtamab Indus Safety Switch for incorporation into a set of selected self-therapy programs. In addition, Moderna exercised an option

on one of the proprietary binders being developed against an undisclosed immuno-oncology target for the delivery of pioneering messenger RNA therapeutics. This license option stems from the deal we announced with Moderna in August 2021. Finally, in January 2023, we signed an agreement with the Cabelletta Bio, which allows them to incorporate the RQRA safety switch into a cell therapy program for the treatment of autoimmune disease. CO dislike

The total license revenue was 6.2 million in 2022 and each of these deals have the potential for additional revenue in near-term option-exercise fees, milestone payments and royalties.

We continue to make steady progress in our manufacturing and CMC operations. The first phase of the build of our commercial manufacturing facility was completed with the handover of the first three clean of the first of three clean rooms at the end of last year. We have named this facility the nucleus.

We're now working on the qualification and validation of the nucleus, and we remain on track for good manufacturing practice operations commencing in the second half of 2023. We're also undertaking the development work and report generation for the CMC package plan to support the BLA submission to the FDA. Finally, total cash and cash equivalent and restricted cash at the end of December were 382.8 million dollars.

from the target cell once the kill has been delivered.

This unique engagement drives maximal activity while minimizing toxicity and is at the heart of the differentiated clinical profile we are observing, A and acute lymphoblastic leukemia, non-hotocin lymphoma patients and chronic lymphoblastic leukemia patients.

Moving on to slide number eight. Our clinical experience with OBSEL in ALL shows high overall response rate across all, sorry, population under it. It shows a high level of clinical activity across all,

median follow-up of 36 months now in this study and with a follow-up of 24 to 47 months of observation we see that 35% of the patients are in long-term remission after receiving OVYcel and receiving no further antilichaemia therapy.

The safety profile is well-manageable with low levels of high-grade CRS and ICANNs. The midsection of the slide shows the patients with long-term remissions and continued presence of CAR-T cells over the entire observation period. The program is developed on their ARMAT, Prime and I-LAP designations. Moving to slide 9.

We completed the enrollment and dosing of a pivotal study, the study we call the PELIC study, in adult relapse refractory ALL patients. And as I mentioned, we announced in December that we have had met the primary end point of overall response rate in an interim analysis based on the first 50 patients followed for at least three months of follow-up. Clinical benefit in ALL will be assessed.

based on patients remaining in sustained complete remission. We conducted this study in 34 centers, 24 centers in the US, 7 centers in the UK, 3 centers in Spain during the peak of the pandemic. It is important to realize that relapsed, refractory adult DLL patients are highly immune suppressed and the pandemic poses a significant added risk to them. Moreover, due to access restrictions and various other pandemic rules and regulations,

with an old access to our clinical trial sites for the most part of the Felix study. You can imagine N-stage ALL patients are about as difficult a patient population to work with, particularly in an environment where there is a high risk of infection, and indeed, within lose patients to COVID.

In many ways, this study was more of a real world study conducted under difficult circumstances. In addition to patient safety, every aspect of product delivery and logistics were pressured tested during this trial, with massively reduced air traffic and impact of the pandemic So, in case we cannot complete it can lead a bit to monochrome, still not available with eating or knowing what to eat.

experienced in less than 3% of patients and high-grade eye cancer neurotoxicity in less than 8% of patients.

ICANNs were fully reversible and less than 25% of patients had any grade of neuro-toxicity. In contrast to approved T-cell or T-cell engaging therapies, a very unusual safety profile in this population. As I mentioned earlier, this exciting data stat trigger A35-

is that the CARP panel and all-COVID-19 study were conducted prior to the pandemic, while both parts of the FELIX study were conducted during the pandemic. Both the CARP panel and all-COVID-19 study were conducted in the UK, while the FELIX study was largely conducted in the US.

What we did picked up is that the patients of the philic study were more advanced in their disease based on Bertuma Burton and increased presence of so-called extra-modalroid disease. This is, in essence, a gain of function of the leukemia allows it to leave the bow marrow and successfully settle and grow in other organs. Patients with extra-modalroid disease respond poorly to any type of anti-leukemia therapy.

Moving to slide 12 to look further into the data we presented at ash from the old car 19 study. When we then look into the outcome or long-term observation from the old car 19 study, we're up to obviously with four years of follow-up and you can see that we have a quite unusual clinical profile.

The clinical benefit in these patients is the ability to convert patients into complete remission and sustain them over long periods of time, which is obviously what we're seeing for a good proportion of these patients. When you look at the swim plot and moving from the bottom up, we have obviously some patients that did not respond to therapy.

Then we have some patients that respond to the relapse quickly. The yellow circles are patients that relapse with so-called CD19 negative disease. In essence, the leukemia became invisible to the therapy by losing the very structure the therapy was designed to recognize. If you then go a little further up, you see three red circles.

There is a patient that relapsed because the CAR-T cells, the OV cell product candidate, didn't persist long enough and patients relapsed with CD19 positive disease. Above those, you then see a group of patients that are in long-term remission between two and four years without any additional therapy.

Seven out of the 20 patients of 35% are in continued remission without receiving any additional antilequemia therapy with median fall off of 36 months in the range of 24 to 47 months. Every single one of these patients has persistent CAR T cells.

You see one additional patient with a long-term remission who received a stem cell transplant while in complete remission. Moving to slide 13, on the site though, a T-cell engaging CD19 targeting monoclonal specific antibody has become the standard of care in relapse refractory adult LL with the last few years. Key to its success has been the well-manageable safety profile.

Key focus from a patient management perspective is the monitoring of neurotoxicity or ICANs which impacts 65% of patients treated with Blincyto. In contrast, OB-CEL had less than 25% of patients experience ICANs of any grade.

High-grade CRS for blincite is low with about 5%, and OB cell seems to be similar and potentially slightly better in terms of high-grade CRS. In contrast to blincite, the OTIC-CARDUS, a CAR-T program approved for this indication, induces high-grade cytokine release syndrome for 26% of patients.

that while active is primarily used as a bridging therapy.

active is primarily used as a bridging therapy. Moving to slide 14.

The market opportunity in the blaster factory ALL is in fact unchanged with about 3,000 patients in high need for therapy between the US, Europe and Japan. Moving to slide 15, the standard of care in the blaster factory ALL has reached sales in 2022 of 583 million with a year over year growth of 24 percent. This product is commercialized by AMGEN. Currently the product reaches about 2,000 plus adult patients with ALL and average on average receiving two cycles of glencyte.

Patients with low disease burden can receive up to four cycles of fluency at a combined cost comparable to CAR-T therapy. Key to fluency is market penetration is its well-manageable safety profile which allows delivery non-academic hospitals in addition to the academic centers.

We believe that OB-cell with its high level of clinical activity, attractive safety profile and one-time administration is well positioned to capture that opportunity. When we look overall in terms of the price level for CAR-T therapies in ALL, they are in the range of $450,000 in the US.

Moving to slide 16. When we look at the steps forward, first of all, we're planning to disclose the Felix data from all patients, Stost, in the mid-2023, likely at ASCO and also at EHA. Long-term follow-up is plan fresh. We're targeting the BLA submission for the program towards the end of the year.

MA filing towards the end of the first quarter of 2024 and the UK filing in the second quarter of 2024. That sets us up very nicely for the key territories that we expect to be initially active in. In addition to the mature clinical data, the submission will also require data from the validation of our commercial manufacturing site. This work has been a key focus throughout the first half of 2023 and will continue into the third quarter.

Importantly, our commercial manufacturing facility is set up to cover supply for approximately two-thirds of the estimated market from the start. As we're moving through 2023, we need to prepare three key areas for commercialization. First, creating awareness for the program through a focused medical affairs program. The program is set up to cover supply for the program through a focused medical affairs program.

Second, establish the value proposition for payers in our HGA doses. And finally, third, prepare for and start center onboarding, a process that will take between 9 and 15 months to get each center ready to deliver CARTI therapy. Moving to slide 18, to talk about the broader opportunity that we see with all we sell.!"

As part of the old car 19 Extension study we have been evaluating OB cell and relapster fracturing on Hodgons lymphoma, acronically lymphaglastic leukemia patients.

We see consistently very high response rates combined with a very attractive safety profile suitable for our patient use. The data will form the basis for the selection of a second indication after ALL.

In terms of the life cycle, we started to work on the next version of Opicel, which we call Auto-122. We're looking to minimize with this product CD19-Antich and Lost driven relapses with its dual targeting approach.

Building on Ob-Cell, we're adding a highly potent CD22 CAR that can recognize very low amounts of CD22 on the surface of leukemia cells. This program was initially evaluated in children who have failed CHIMRIA or were not eligible for CHIMRIA therapy. In this very challenging patient population, we saw an 83% molecular response rate.

and none of the children relapsed with the NOAA CD19 negative disease. Comparing this activity to OV cell, we would have expected a molecular CR-8 of approximately 40, maybe 50%. We're working on further streamlining the manufacturing process for O2122, knowing that we have an attractive life cycle option. Timing of investment decisions in O2122 will be balanced with additional indication investments for OV cell. Slide 19.

Our strength in T-cell engineering drives our pipeline and is also at the heart of the three collaborations reported on in 2022 and early 2023 with Moderna, VMS and Kevilleta. On slide 22, we have a quick summary of the earlier stage programs in T-cell in Pharma with auto 4.5, auto 6.0, NG in Nuraplastoma and auto A in multiple myeloma. Both auto 4 and auto A are in phase 1 clinical studies.

At autostics, NG is expected to start phase 1 in the next quarter. Moving to slide 23. CISEL and Phoma has a very high medical need, quite similar to BAL. In fact, when you look at the NCCN guidelines, it is basically where basically says that once you through the front line therapy and fail, you have to go on a clinical trial.

Moving to slide 24. With its unique targeting approach, all the four starts to show meaningful clinical impact at the higher dose levels that we have evaluated. The first metabolic CRs are reaching one-year post-streatment and we continue to follow those patients. In addition, we have streamlined the manufacturing process and are exploring the activity in an additional cohort and we're planning to report on that outcome later in 2023. Moving to slide 26 to talk about manufacturing. Cell manufacturing is at the core of any antologous self-therapy.

developing a highly reliable robust and economical process is critical for the success of any program. In addition, we have to be able to deliver product at scale and matching the capacity to the size of the medical need in its indication, and it is important to be able to do that to have a successful rollout of your therapy. Building on the robust and well-directed, well-directed process used to manufacture a...

for batches per year, or about two thirds, all the adult-day-lL market size in terms of capacity.

The nucleus has been a fantastic project to realize with an innovative design and about 75% off-site building to accelerate the build while maximizing the quality of the build.

So with that, I would like to turn to slide 28 and pass the call over to Lucinda for our fiscal year 2022 financial update.

Thanks Christian, good morning or good afternoon to everyone. It's my pleasure to review our financial results for the fiscal year to December 31st 2022. Cash and cash equivalents and restricted cash at December 31st 2022 total of 382.8 million dollars as compared to 310.7 million dollars at December 31st 2021.

Next, total operating expenses for the 12 months ended December 1, 2022, or $168 million. Net of grant income and licence revenue of $6.4 million. As compared to total operating expenses of $165 million, net of grant income and licence revenue of $2.3 million for the same period in 2021. Research and development expenses increased by $7.2 million.

to $142 million for the year-ended December 31, 2022, from $134.8 million for the year-ended December 31, 2021. This was primarily due to the following. An increase of $11.6 million in critical costs and manufacturing costs primarily relating to our self-critical product candidate. An increase of $0.4 million in legal fees and professional consulting fees in relation file are indeed excellent. An increase of $0.2 million related information technology infrastructure and support.

due to lower exchange rates used upon consolidation for the year ended December 31st 2022 compared to the year ended 31st 2021 and this is offset by an increase in employees engaged in R&D activities.

General and administrative expenses remain consistent at $31.9 million to the year end of December 31, 2022 and 2021. Respectively primarily due to the following, an increase of $1.4 million in salaries and other employment costs, including share-based compensation expenses, mainly driven by an increase in the average number of employees.

engaged in G&A activities. An increase of $0.3 million, primarily related to information technology costs, and that increases of $0.1 million in legal fees and professional consulting fees and relation to our G&A activities, which will set against lower D&O insurance, Director and Officer Insurance. A decrease of $1 million of commercial preparation costs due to the time we have related activities.

a decrease of point-4 million dollars in facilities costs related to determination of certainly agreements in the prior year and a decrease of point-4 million dollars in depreciation and amortization related to property and equipment and intangible assets. Interest income increased to $1.7 million for the year-ended December 31st 2022 compared to $0.3 million for the year-ended December 31st 2021. The increase in interest income of $1.1 million relates to the increase in interest rates on our interest bearing bank accounts and short term investments during the year-ended.

December 31, 2022 compared to 2021. Interest expense increased to $8.9 million for the year ended December 31, 2022 compared to interest expense of $1.1 million for the year ended December 31, 2021. Interest expense is primarily related to the liabilities for future royalties and sales milestones, which arose upon the execution of our strategic collaboration and financing agreement with Blackstone in November 2021. The increase in interest expense for the year ended December 31, 2022 is primarily driven by

the full year of the liability related to the Blackstone collaboration in 2022 compared to a partial year liability accrued in 2021. Other income or expense increased to an income of $2 million for the year-end of December 1, 2022 from the expense of $1 million for the year-end of December 1, 2021. During the year-end of December 1, 2022, we recognised a foreign exchange gain of $1.7 million, a sub-leasing, a $0.2 million, another income of $0.1 million. This compares to an expense of $1 million as I mentioned for the year-end of December 1, 2021, which included a

and $42.1 million for the same period in 2021.

The basic and diluted net loss for ordinary share for the 12 months ended the December 31, 2022, totaled $1.57. Compared to a basic and diluted net loss, the total of $1.97 for the 12 months ended December 31, 2021. Finally, it also estimates that its current cash and cash equivalents on hand and anticipated?is expected quality of our daily shared ministerial data.

targeted towards standard year, followed by filings in Europe in the first half of next year. Next up are the Plan Felix Data Presentations mid-year 2023. In addition, we are preparing for commercial product supply and launch readiness. Finally, we also expect to provide updates on the pipeline programs with additional data and follow-up during the year, and with our key programs on-partner at this stage, we have opportunity for setting up collaborations.

Moving to slide 31. So with that, we believe we're at an interesting, very interesting point with the company. We've got the cash to deliver a very significant value step. We got the data to show that with OB-SEL, we have a differentiated product profile that addresses the high medical need with limited competition and with possibly a transformational outcome. Alongside that, we have additional opportunities for OB-SEL in broader indications and a valuable pipeline of other oncology programs. As I mentioned, we're excited about our manufacturing facilities and what facility, and we have a strong technology foundation validated by our collaborators, CMS, Moderna, Capaleza.

And we look to do more details of that nature in the future. With that, thank you very much, and we're happy to take questions. Thank you. To ask a question, you'll need to press star 11 on your telephone. To withdraw your question, please press star 11 again. Please wait for your name to be announced. Please stand by. Will we compile the Q&A roster? One moment for our first question.

Our first question comes from the line of Gil Bloom with Needham and Company. Your line is now open. Good morning and good afternoon and thanks for taking our questions. It's just the first one on the data that was published from the Felix study. So there appear to be a slightly higher incidence of grade 3, Sarah's and I can'ts than kind of earlier studies.

Now given that Autolith's goal is to have Obacel administered in the community setting, how do you think physicians will adjust to levels of high-grade AEs? Gil, first of all, thanks a lot for joining. Really good question. So I think it's important when we put the data in perspective, what we did show is that we have less than 3% high-grade CRS and we have less than 8% ICANs. This is a level of grade 3.

events in both for both types of adverse events that is at or below the level of purple insight though which is currently used in non academic centers. And so we believe that actually the profile is very well suited and matches the experience actually already established with the standard of care in those centers to believe the data is very well suited and the supportive of that broader use of the product. Yeah, that's very helpful. And another question about the fire line. So what data do you expect to include in your BLA? I mean, um...

you're going to have additional data by the filing date, including ORR and the duration of response, but will you also be including data from your MRD positive cohort?

So, really good question. So, first of all, in terms of our, you know, of demonstrated clinical benefit in the morphological cohort, which are patients that have more than 5% disease burden at the time of inclusion into the study, the focus is to demonstrate that you can actually convert these patients into complete formation.

that are sustained over time. So what you will have to look at is CRs with a minimal level of follow-up to actually establish an appropriate level of clinical benefit. So time-dependent outcomes are absolutely a critical parameter that will have to go into a BLA and will be at the core of the assessment of clinical benefit for the product. Second, of course, the safety profile was then a key part of the assessment for to understand actually the benefit risk ratio that you have with the product, which is obviously very key.

with morphological disease. The work that we do to expand the knowledge of the properties of the product across the entirety of disease burden, which includes, as you pointed out, all the patients with mineral residual disease, is a data set that obviously is being generated, but it is also a data set that is not going to be part of the initial filing in terms of, we'll go into the safety program.

it is not an aspect of the efficacy evaluation for the initial filing that we're planning. Last one for Moss, if you've mentioned that from your scientific collaborator, there may be some data on multiple myeloma. What do you think the gating factor would be for further development of that program given how crowded the market is? Thank you. Yeah, very good question. So what you're referring to is the auto-Aid program that we're working on with our colleagues on the academic side. We're currently running a phase one clinical trial to evaluate the activity of auto-Aid in relapse refractory multiple myeloma patients. I think we're in an interesting spot with regards to the CAR-T therapy.

and these patients to as a basis to consider taking the program forward. And if we're at that point, clearly would anticipate that this would make sense to do in a partnership. Okay, thank you, Gil.

Thank you. One moment for our next question. Our next question comes from the line of Mara Goldstein with Mrs. O'Glook. Your line is open. Great. Thanks so much for taking the question. First of all, on the multiple mile on what data that you do anticipate having this year, can you just...

What, how you plan to position OBSL? Yep. Hi, Mara. Thanks a lot for the two questions. So the first question was related to the ORO-8 study. The ORO-8 study is a small phase one clinical study so we're looking at around temptations.

So the initial experience and then we'll take it from there. So it's going to be an initial look at that at the profile of the product in that initial set of patients.

Now with regards to OB cell, what we're expecting to go for is obviously a positioning of the product in the relapse refractory setting, whether patients have had already received glint side dough or a post-glint side dough.

And I think that is sort of obviously what the current study actually is evaluating, it's patients that have very advanced disease and with a portion having had blimcytosin or inatuzumab or on a portion who didn't. So you're looking to position the product both in parallel or after blimcytotherapy. Obviously the tachycardis is obviously positioned in that exact same way, so it would be the same type of decision.

question. At the recent European CAR-T meeting, Kite and we had presented some long-term follow-up from Zuma3 with ticardis. And it shows very few patients really remaining in CR even beyond two years. And so it's pretty big contrast to the data you presented at ASH from follow-up with All-CAR 19, 35-40% of patients still in CR at three years.

So do you expect the field state to recapitulate the all car 19 durability given you've talked about a little bit tougher to treat patient populations with extra modular disease and such. And I guess just how do you kind of get that durability message across to physicians in your kind of education process? So really good question. Thanks for joining, Matt.

It's really what you're pointing to is really kind of the I think what we believe was really remarkable data from our initial evaluation of OB cells in this patient group and obviously as you pointed out what we did see is a stabilization of our long-term durability curves etc with you know patients staying in sustained permissions about

as you pointed out, 35% of the patients being in that category. So that is a remarkable outcome. And it's clearly something that has not been passable when I developed with my old team, Glenn Saiton, have not been shown clearly, not be shown with the cargicide. So what we're looking, what we're expecting to see with OVCEL also, the feeling studies that we also see a similar shape of the curve, where exactly that stabilization will ultimately occur. I think that's too early to tell. We don't have enough to follow up in the study at this point in time. But that is what we're looking for, and that's what we expect to see. Whether it's going to be the exact same level or a slightly different level, we do not know at this point in time.

long-term follow-up. The fact that we saw the persistence data track what we had seen before I think is very encouraging because obviously that was a clear correlation that we did see that all these patients that had long-term outcomes also had long-term persistent CAR T cells and the shape when you look at persistence coming out from the trial as we had indicated from the interim analysis was tracking the old car persistence.

So that is encouraging, I think, is sort of a leading indicator, but all of the requires long follow-up to sort of be clear about where exactly we might be landing. Okay. Can I also, what point do you request a pre-BLA meeting this year? Is that the new due after kind of the ASCO update? Sure. So it's a really good question. So I think what you want to do at the time you go for a pre-BLA meeting is...

You want to actually have the data with sufficient level of follow-up. So you have a very clear positioning around the outcome that you can actually present and discuss with the agency. And obviously the data we're going to go with into ASC, I think, will start to give us I think a good level of observation. So we would expect that this is going to be an interaction process. Let's go.

to actually have the data with sufficient level of follow-up. So you have a very clear positioning around the outcome that you can actually present and discuss with the agency. And obviously the data we're going to go with into ASC I think will start to give us I think a good level of observation. So we would expect that this is going to be an interaction post-ASCOL. Thanks, Christian. Thanks, Christian.

You know, the data with sufficient level of follow-up, so you have a very clear positioning around the outcome that it can actually present and discuss with the agency. And obviously the data we're gonna go with into ASC, I think we'll start to give us, I think, a good level of observation. So we would expect that this is going to be an interaction post-ASCO. Great, thanks, Christian. Okay, thanks a lot, Matt.

Thank you. One moment for our next question. Our next question comes from Kelly Shee with Jeffries. Your honor is now open. Congrats on the progress and thank you for taking my question. Regarding the baseline for patients in road and in the Alex trials, does it appear consistent with place 1B cohort on the extraction of patients with greater than 10% of the bone marrow blood and also will be able to provide more information such as patients with the CSSBVs and the actual majority of these presence on the phallic trial. Thank you. I have a follow-up. Okay. So thanks for joining Kelly. Nice to have you on the call. First of all, in terms of the patient population, overall up to the patient population is closed and very close to what we've been seeing in the phase 1 portion of the study. And what we expect to, what we also expect to see is obviously some variability after sort of going through the peak pandemic into study.

Thanks for the question. Well, what you're pointing to is a really remarkable data set that was developed by Andreas Markinson and his team at the University of Erelohn, who've done a fantastic job evaluating the utility of the CD-19 CAR T approach and patients with refractory systemic lupus. The outcome of the data was quite remarkable. It's a nature medicine paper.

outstanding safety profile, which is important when you think about use in autoimmune disease. And the other aspect, of course, is that as we all learned in this space, the fundamental tricky part with the thologous carpath therapies is you actually have to have an ability.

to manufacture at scale and do that at quality and economically. And obviously that's one of the key things we have been developing for OVCEL for its initial application in ALL. So absolutely we're following that field very closely. We think it is a very attractive potential future use of programs that are very safe and very active and we'll leave OVCEL to its staff very well. Thank you.

Thank you. Thank you. Thank you. And our next question comes from the line of James Shin with Wells Fargo. Your line is open. Good morning and a half of you guys. Just a couple from RN. I just want to dig a little deeper into the positioning of OBSEL. So do you envision OBSEL could be positioned ahead of Blinside to at some point?

And is there a future study exploring this? And then on a related matter, I mean, South therapy as a whole has started to make good headway to the earlier with a couple oncologists. These are some regulatory hurdles, namely the fact immune effector cell accreditation that makes South therapy entry in the community setting a little bit.

difficult or intensive. Any thoughts there? We'll appreciate it. Yeah, well, first of all, thanks for joining, James. And I think, you know, a very interesting question. So first of all, in terms of sequencing, you know, at this point in time, obviously, Plentite is approved both in the relaxer factory setting, as well as obviously in patients that have been or were difficult with these and that are basically in CR1 or later. So in essence, it's patients that have gone through frontline therapy.

with still remaining residual disease, they're technically in complete formation, but they still have measurable leukemia cells at low levels since minimal residual disease. And so the product is obviously has labeled in those two settings, and obviously has been evaluated now as part of the frontline therapy. So that sense, Plinti-Bohaz will have a place in this earlier part of the treatment scheme, and we expect it to just sort of move up into that earlier setting. Now what we see from the the Dicartis approval age that Dicartis was approved.

But that obviously takes time to actually move up in terms of the lines of therapy.

So I think that's the first part of the question. The second part of the question was more around how do you actually position CAR T therapy outside of the academic centers considering that you need a level of training or accreditation of those centers to be able to actually deliver the product. I think what we need to understand is that particularly with OB-CEL...

So when you look at that, that population that has low particular lower disease burden, but even the one that we have treated now, the adverse event profile that we have in these patients is exactly what the physicians today do manage with glidsido. The same level of higher rate turets, in fact, is a little less than what glidsido have.

you to monitor the patients, to observe them, and set trap, make sure that you stay a couple of days.

What we have with OV cell in a more advanced patient population because I was to be include inside to a failure in the phylic study, we actually have a little more than 20% of patients that have some form of neurotoxia. So it's actually substantially less. For the actual monitoring level is less.

that we have, and with that we believe there's an opportunity to actually manage this, and with the experience of which I should be able to manage this, in non-academic hospitals and associated potentially outpatient settings sample I.

So that is sort of where that is. In terms of the ability to deliver CAR key therapy, there's obviously a level of not only patient management that's required, which is covered very well with the experience of things like that. But it is also obviously required to actually handle the cells and manage the cells as part of the therapeutic approach. And that requires a level of training that obviously needs to be put in place.

And we believe that that is a possibility for non-academic hospitals. And then we have to see how further, how further out you might actually be able to go. But I think this gives you a very good penetration and ability to reach the AOLO population with this profile as we see and basically demonstrated through the insights already.

Thank you. Thank you. One moment. And our next question comes from the line of Sebastian Zanneskou with Van Schatz-Timper. Your line is open. Hi. Good morning. And you have been in Berlin for a while. It's Sebastian van Schatz from the Netherlands.

No worries, congrats on the projects. I was just wondering at the opportunity of all be selling other indications beyond the ALL. There will be additional updates on the ALCAR study for the other indications with additional patients. And are there any of these indications that you believe would allow for an accelerated approval pathway after additional data can show the same level of efficacy as this code at S last year.

And then you also spoke a little bit about the life cycle management of the AUTO 122. Can you expand on your thinking on the possibility to continue development of AUTO 122 beyond the pediatric indication into adult hematologic indications? Thank you.

Thanks, Sebastian. Thanks for joining. So when we look at the opportunity that we see with OVSEL, obviously what the product is, you know, has a remarkable profile in these two, basically, removes the B-cell compartment, those on Malignant cells, as well as healthy cells, and do that with a very good safety profile. So that's the basic property of the product, where that is suitable, obviously, is in...

leukemia, it is in non-Hodgkin's lymphoma, which is what we're evaluating and CLL what we're evaluating as part of the old current IT study. And then as Kelly was pointing out, there's also certain applications in the autoimmune space where that might become quite interesting and some elite data would indicate that you might even be transformational in those settings. So this is sort of the range I think you have in terms of opportunity.

of the indications, and that is also a lot of confidence in terms of the overall quality of the product. In terms of the individual indications, obviously, you know, you have opportunities looking at the ODCL as an example where we see, you know, very high level of the complete permission that are sustained. We haven't seen any remapses today.

in that cohort, which is quite remarkable. There are also very interesting data in mantle cell as well as the sea level that we have seen. Now all those indications are opportunities to develop in segments of the indications.

which allows you to move relatively quickly and with accelerated path. And then depending on the indication you look at, you also made an animal to altitude so we go for a last-line fitting. We'll want to actually start looking at an earlier line, a study as well, which is typically what the other line of control study in that earlier line. I would want to move on that reasonably, and they're reasonable to the time of relation to your last-line fitting.

So that's sort of the opportunity and we're looking at these and over to the data from the old card data old card study does give us I think a very nice basis to sort of you know Develop the right options for the investment You then also asked about the how in that Conversation how all the one 32 please and as we indicated We also do know that with all the one 32 that we have a very active program Fears to do exactly what we want in terms of avoiding The occurrence of target negatively lapses which is the key thing that I'll see if the looking to address

And where we know that is particularly important to these. Obviously aaccudlekemia, there been initially reports that there is a certain proportion of patients that do actually show cani negatively elapses in IND case in the context of the food docks we se and ll-up. They haven't been as many reports more recently in our own hands and winido sell we haven't seen.

I think negative relapse is not able to handle the problem. So, or of three. So, whether or not that is a major issue to address in those indications, I think it's unclear at this point this time. And I think that is one of the questions I think will look into the ability to broaden the ability of the dual part of the approach into additional indications. So, where it's very clear, we've said that the in ALL, and he certainly is ready for results, those for children, others for adult patients, and we believe it's up to point, it makes sense to consider.

that program to move into the succession of a B-cell in the acute latinia setting as well. So that sort of, I think, is terms of the range as well as the way we're thinking about it. Ultimately, it's at these are set of investment decisions and it's this question sequencing those investments. And I think the priority will first be on actually broadening the opportunity for OBSEL and then in a second step actually moving forward with OLOON 32 in terms of the actual nice cycle of OBSEL.

Great, thank you very much. One moment. And one moment, our last question comes from Africa. I'll go on awarding with Truj Shilana's open. Let's open.

Hi, this is Karina for Austria. Just have two questions on pricing. What is the silent deal by Europe and how are you best thinking to price? I'll be so and can you also discuss some preliminary feedback here which you compare in the US and Europe . And also is there any potential for your pricing power change with detailed data at ASCO? Thank you.

Sorry, Karina, I didn't get the last part of the question. The pricing power with the next updated ASCO. Oh, I see. Thank you. Well, first of all, thanks for joining Karina. Interesting questions related to pricing. I think what we've been seeing across the state is to the two dimensions. First of all, we're having in-anl typically, also with Lyncite, though, and the use of Lyncite, though, in patients with lower-to-deep burden, we also do see.

use of up to four cycles in those patients, which is basically getting the price for that product into the range of between $400-500,000 per patient in the US. So that's sort of one benchmark, which is standard of care and kind of where and what bracket that is. When you then look on the approved CAR-T therapy in ALO, that is in the range of $450,000 during the course expected to be during the course of this year. So that's sort of the second sort of I think bracket that we're seeing in the US. And we would expect that we would be pricing in a similar range. Obviously we believe that we do have...

The product that actually allows you to be more efficient from a cost perspective because the product should be due to less toxicity with higher-less patient management. With that, I think there should be a good healthy, phenonic argument supporting the use of OBSL in relation to obviously its clinical profile. With regards to Europe , where OBS is seen across the board with CARKEE therapy, the prices are starting in the range of where the US.

in seeing in the space. In terms of data flow, I think we're gonna have a very interesting data flow as we go through this year. We'll see at ask of the data from all the patients that were those, but also still a limited follow-up on some of the patients that I think is focused on a lot of the descriptions of the patients, the basic activity, the behavior of the product in every aspect, and then I think as we go to

ASH and then even later into 24 I think obviously much more longer term for which will I think will flow obviously as an important parameter into the HGA assessments and value assessments that will be conducted by the payers. So that's kind of think where we are with those particular questions.

Do you think the longer term follow-up is going to push pricing higher? Well, first of all, what is the impact of the longer term follow-up and showing an impact on longer term follow-up, I think is obviously strengthening your value argument before the product. So I think it will clearly make a very strong case for using the product based on more patients achieving long-term outcome. And I think that is certainly going to be a key parameter that will drive the value assessment by anyone who would look at it.

programs. So we'll definitely influence the overall assessment to what extent that would influence pricing. I think it's premature to discuss. Okay, thank you. Okay, thank you, Karina. Thank you. At this time, I'd like to turn the call back over to Mr. Christian Eaton for closing remarks. Well, first of all, thanks everybody for joining. Obviously it was great to be able to update you on a very exciting fourth quarter that we're running through. I think a very important stretch as we go to the course of this year, again, the product ready for filings. And I think I would say a real opportunity for...

Ladies and gentlemen, thank you for your participation. And due to time limitation, we were conscious of the time and we weren't able to reach out to everyone. So management will connect with everyone that weren't able to connect to the call after the call. Thank you very much. Please enjoy your day. You may now disconnect.

Q4 2022 Autolus Therapeutics PLC Earnings Call

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