Q2 2023 Autolus Therapeutics PLC Earnings Call
Yeah.
Hello, Ladies and gentlemen, and welcome to the ATA list Therapeutics second quarter 2023 financial results conference. At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During the session you will need to press star one on your telephone.
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Please be advised that today's conference is being recorded.
I'd now like to hand, the conference over to your host Julie Wilson Communications consulting. Please go ahead.
Thank you Cory good morning, or good afternoon, everyone and thank you for joining us to take part in today's call to Akshay <unk> second quarter 2023 financial results and operational highlights.
Eddie Wilson communications consulting for auction.
With me today are Dr. Christian <unk>, our Chief Executive Officer, and Dr. Lucinda Crabtree of 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, which are forward looking into federal securities laws and the safe Harbor provisions of the private Securities Litigation format. 1995. These may include but are not limited to statements regarding the stages of clinical trials and development and regulatory.
Timelines for our product candidates and our expectations regarding our cash by law. These statements are subject to a variety of risks and uncertainties that could cause actual results to differ materially from expectations and reflects turkeys any as of today and we assume no obligation to update any such forward looking statements for a discussion of material.
Risks and uncertainties that could affect our actual results. Please refer to the risks identified in today's press release and SEC filings available on the investors section of our website.
On slide three you will see the agenda for today's call, which is as follows Christian will provide tonight is our operational highlights for the second quarter of 2023, NUCYNTA will then discuss the company's second quarter 2023 financial results.
Christian will conclude with upcoming milestones and any other concluding comments finally, we will welcome your questions over to you Christine.
Christine.
Thank you Julie and good morning to you all thank you for joining US it's my pleasure to review our progress for the second quarter of 2023 moving to slide four we had a very productive second quarter with the <unk> EHR data presentation of our pivotal field study is to highlight <unk> has shown an excellent profile in adult patients with relapsed refractory occur.
Lymphoblastic leukemia, the RR based on complete remissions with either complete or incomplete Hematological recovery was 76% up from the interim analysis, which came in at 70%.
Safety profile, which was remarkable with low levels of high grade cytokine release syndrome and ICANN.
And the data tracks very well on persistence and duration of response with our prior <unk> study, where we have seen 35% of treated patients in long term remissions without any need for additional anti leukemia therapies.
Next follow up is planned for ash with several <unk> related abstracts submitted to the organization. This week.
Critical for the successful outcome of the Felix study was our robust product delivery platform with high manufacturing success rate short way to delivery time and high percentage of patients dose without b cell key focus now is on the completion of the validation of a commercial manufacturing facility, which we call the nucleus. We're.
We're on track for a filing of a biologics license application with the FDA at the end of 2023 and a market authorization application with EMA in the first quarter of 2024.
As the program is progressing towards the regulatory review. We're also actively preparing ourselves for launch with critical activities underway and medical affairs completion of value dossiers and onboarding of clinical centers.
On slide five we have a short overview of the key pipeline progress first we continue to expand or we sell the ob cell opportunity and our Hodgkin's lymphoma, and our old car 19 study, we demonstrated very high levels of metabolic complete remission rates in patients across a b non hodgkin's lymphoma indications with an attractive high level of some.
<unk> patients we have also notably taken the decision to develop both ob selling autoimmune disease, starting with a small phase one dose confirmation study in <unk> patients, which we expect to start early in 2024, we believe the excellent safety and efficacy profile, we have seen for Ob sale in <unk>.
Hodgkin's lymphoma patients will translate well into b cell mediated autoimmune diseases and together with our established commercial manufacturing and delivery base plus attractive Cox will drive a bell differentiated expansion of the <unk> opportunity.
Looking into obviously, a lifecycle the pediatric ALLL carp health study with <unk> 22 was updated at the <unk> meeting in the second quarter and continues to show an impressive level of clinical activity in a very favorable safety profile.
Also in the second quarter, we presented longer follow up of the peripheral T cell lymphoma patients treated with <unk> four showing complete remissions narrow sustained beyond one year.
Finally, and also in collaboration with UCL Auto aid is progressing well in the face of our multiple myeloma Mccarty study with the first data planned for the end of the year and finally auto <unk> Phase one study in neuroblastoma is expected to start in the third quarter.
Turning to slide number six and to tell you a bit more about how we are strengthening the <unk> team. We had a very busy second quarter with great additions during the second quarter I'd like to start out with Dr. Robert <unk>, who joined our board of directors in June <unk>.
<unk> brings to Atlas a wealth of experience in the life science industry, having worked across a broad range of therapeutic areas in phases of development, including immuno oncology programs at jazz Pharmaceuticals, Immunomedics, Astrazeneca and Merck and company. We're obviously a great addition to the board and brings obviously very relevant experience as we're going through the regulatory.
Tori review process in the U S and elsewhere.
And obviously is really instrumental in the further development and positioning of the product.
In July we announced that <unk> will be succeeding with seem to crafting as chief Chief Financial Officer, Rob has more than 20 years of very very diversified experience in the life Science financial executive and joined <unk> from Checkmate Pharmaceuticals, where he served as the CFO and was a key member of the team driving the sale of the company to Regeneron prior to that Rob had key.
Leadership roles at operational roles at both human genome Sciences at Amgen.
That was on the call with us today and I'll ask him to give a quick introduction later in the call.
At the same time as we announced drops appointment, we also announced that Dr. Veronica Harrisburg or had been appointed as senior Vice President Medical Affairs, Veronica joined us from target between a private Swiss oncology company, where she served as the Chief Medical Officer. She brings a long career in oncology development Medical Affairs.
Remarkable level of experience across a wide range of products. During her time at Astrazeneca Veronica was a global product leader for both <unk> and prior to that she served as the global head of medical Affairs for the hematology franchise at Roche.
Where she was also involved over the years in the development of a wide range of oncology programs.
Finally, Miranda Navelwort promoted to senior Vice President product management heading up the <unk> program Miranda served in various roles at <unk>. Most recently as Vice President head of program and portfolio management.
And has over 20 years of experience in project management engineering capital projects and operations prior to leading the Ob cell program around around <unk> commercial manufacturing capital product delivering the nuclear facility in record time.
Prior to <unk> Miranda supported several consulting projects for large biopharma companies as well as clinical stage gene therapy programs at companies like human genome Sciences, and others and particularly at <unk> Sciences Miranda led.
Benlysta program in SLE through the successful BLA, and then obviously, resulting in regulatory approval and launch of the product. So.
So we're expanding the team with very experienced set of industry leaders.
In their respective fields.
Obviously all of them are having a significant impact already and we continue a lot of contributions in the future.
With that I'd like to actually switch over to Ob cell and removing two slide number eight.
Here I would like to take the opportunity to really give you a quick update and summary of the key data that we presented both at <unk> as well as the DHA from Felix data.
As you remember the patients that we enrolled were relapsed refractory patients.
That had been extensively gone through extensive lines of therapy prior to actually being eligible for the study. The primary endpoint. We're looking for is overall response rate based on CR Cri and we're obviously looking at secondary endpoints that look at the duration of response event free survival as well.
Is overall survival and the ability to convert patients into an <unk> negative status status.
We have enrolled 112 patients in this study we infused 94, so 84% of the patients involved we are actually dosed with the product.
You can see in the slide also.
Difference between the Angola, and infused patients and kind of what the key characteristics work.
Now when we look at the baseline characteristics that would indicate that these are clearly.
Advanced patient population, we are somewhat older patients. When you look at the average age of 15 years at somewhat of a bulk of what we've seen in prior.
<unk> studies in relapsed refractory AML.
And certainly not an easy population.
To work with we see obviously, a well balanced between <unk>.
<unk>.
The usual type of level off.
Philadelphia chromosome positive patients and prior types of therapies.
What I'd like to point out that at the at the bottom is our stated the patients did have high levels of tumor burden in their marrow.
And also we had a.
The proportion of patients.
Extra medullary disease, which are known to be very difficult to treat and to manage.
Moving to slide number 10.
This is the overall response rate as you can see we had an overall response rate of 76% 54% of the patients achieved CR, 21% at Cri and we have seen a very high level of patients achieving not just at the complete remission, but also in <unk>.
<unk> negative status with a sensitivity of 10 to the minus four.
Now when we look at duration of response. Obviously this is still early in terms of follow up with a median follow up of nine five months that you can see that.
Overall curve tracks very nicely with what we had expected and seed prior but it could also see there is still in a significant number of patients in the earlier part in the upper part of the curve, which tells you that there is still quite a bit of observation that we need for the study to actually for this curve to fully stabilize at this point, 61% of the responders are.
Ongoing remission.
Now when we look at on slide number 12 into sort of a bit more into sub analysis of kind of what's driving or impacting.
The overall response rate, we do see obviously key drivers here, what I'd like to point out as indicated before patients that have extra medullary disease.
And to have a poor outcome as our patients that have very high levels of disease in tomorrow. In fact, if you have patients that have more than 75% tumor burden and the borrowings.
A reduction of the overall response rate to the range of about 60%, whereas patients with the disease burdens below 75% of the macro and extract any level below where in that range of somewhere between 80 and 85%.
I think it's also worthwhile pointing out and not a surprise that obviously if you have patients that had a very significant number of prior lines of therapy. They tend to do less well than patients that have been less.
Exposure to therapy before.
And overall, obviously some limited impact that we can see on either prior or prior.
Tumor map therapy. However, those are what's the overlapping so from a confidence throughout not clearly differentiated.
So with that moving to safety.
As you can see on slide 13 quick summary on the immunological toxicity that we haven't served we looked obviously specifically for cytokine release syndrome, and neurological toxicities as measured by ICANN.
I think it's remarkable when you see overall that we have a remarkably.
A safe product.
The overall Crs level, we had.
About 3% of patients that had experienced high grade Crs, which is very low compared to any other I think therapeutic approach that utilizes T cells, including plane side, though.
We look at the ICANN, we also see that the level of higher grade ICANN is low at 7%, which is also below any of the other therapies that are redirecting T cells.
I think overall, we do see somewhat of an impact on tumor burden.
I can but we don't see much of a difference in terms of tumor burden of cytokine release syndrome on I can see you can see that there are patients that have more than 20% tumor burden that the icons are elevated we have 10% of patients that has ICANN. If youre below 20% you have a very low probability of experience of high grade ICANN.
What was quite remarkable to us that most of the patients that experienced the highest rate.
Total seven patients either with 94.
<unk> actually have more than 75% tumor burden at the time of lift for the patient.
So this is after bridging therapy and everything else you could do to contain the disease prior to dosing thats still in excess of 75% and Thats. The group of patients that actually have the highest risk which also actually gives you very important information ahead of dosing the patient on what you expect to manage pace.
Going forward I think puts to physicians in control of this therapy.
Rather than basically being finding themselves in a position where they factor being taken for a ride.
Now moving to slide 14.
As you can see one of the key parameters that we've been looking at it obviously the behavior of the T cells into patients.
Remember one of the unique properties that we have with Ob salaries that it is obviously a product that has a very unique design. The design allows us to get a very seasoned logical engagement.
All of the targets out rapid recognition rapid scale and in a rapid user engagement after that character Kurt added the ability for themselves to recycle back into action.
But asset cycle back into action again, theyre not only actually continue in a serial killing mode, which actually is at much much lower level of toxicity overall, they all to actually give a very strong signal to proliferate.
So one of the things that we do see across all of our patients is a massive expansion.
Of the car T cells in vivo.
Which gives us enormous peaks that you see on the left hand side on slide 14.
Which in fact matches very nicely the peak of expansion.
Total number of car T cells.
Over time.
Matches very nicely with what we have.
You have seen in our prior study Youll Carmike heat study when we look at the area under the curve for the first 28 days also very nicely matching if you look at the half life very nicely matching our prior experience and as we've seen with old car before we do see a sustained level of car T cells over time and Macy's.
Important because as we go to slide 15 as a quick reminder, the observation of wells in the old car 19 study you can see on the right hand side is that very similar behavior of rapid expansion.
<unk> levels of car T cells over time as you can see we look here up to four years.
In the old car 19 study and we also did observe that all of the patients.
It had long term remissions without any additional therapy, which of the patients at the top part.
Swim plot of left hand side all of those patients had sustained persisting car T cells. So we believe actually having seen a replication of the several properties in our Felix study tracking what we have seen in the old car study gives us a high degree of confidence that we're on.
On the right track in terms of the longer term follow up as well.
Moving to the summary on slide 16.
Obviously, we're very excited with the outcome that we have seen in the study remember as a backdrop. This study was conducted through the peak of the pandemic.
We're not able to go out to the sites everything was done remotely.
And as you can see and it's also reflected in the patient population, we have a wide range of patients a patient with extraordinary risk factors, which actually normally you wouldn't see recruited into studies like the <unk> study. So we have a very much a real world patient population that we've treated here and to see the outcome both.
Efficacy as well as on safety to be so consistent with what we've seen before it gives us a lot of confidence in the property of the product, but also with our ability in our ability to deliver the colon reliably a high level of quality at a time, where these patients which is really critical.
When we then look at the.
The Grasberg desperate just talked about obviously, we're tracking with what we have seen in our prior experience with the program and that would obviously it gives us a lot of confidence in the further analysis and follow up of the study.
Now I'd like to spend just a two or three minutes on manufacturing if moving to slide 18, and I just want to briefly talk about what is the critical success factors on product supply.
The first days.
When you're dealing with patients with acute leukemia, you actually started with a very challenging starting.
Many of these patients do not currently have disease in their bone marrow, but also actually have disease that actually.
Yes. This is mark.
Basically.
Leads to very high tumor burden Olson.
Collecting samples.
From the graph in the Leukapheresis.
You have patients where you have the predominant sales that you've collected up to 95% of the sales can be leukemic cells and as you can imagine that's an incredibly difficult starting with euro because you have to first get rid ourselves before you can even think about manufacturing.
It means that your manufacturing process.
Well to handle a wide range of very complex and challenging start in the field. So we spend a lot of time optimizing the manufacturing process to actually achieve the level of robustness that is required for reliable product delivery here.
The other aspect is that you want you need to have very consistent.
Turnaround time recently kind of consistent.
Production time.
The NDA is consistent product release side, which is the analytics that lead you to a full battery because it allows you to.
To release the product.
That actually is a very very important part because we think that overall turnaround times and what actually allows us to actually be consistent at all to manage our overall cost has to do with the fact that we operated with fully fully enclosed system that actually allows us to operate in a lower grade clean room environment that what you typically.
This is a space that actually the mass reach the massive reduction.
And that it takes for people to get in and out of those particular routes. So thats actually directly impacted costs, but it also has much less roaming cost involved and it also simplifies the whole approach because it allows us to build on a semi automated level of semi automation, which also reduces the actual handling steps.
And with that increases robustness, but also decreases cost net people are critical here and I think we shouldnt underestimate the importance of the PC market.
And the people you have to train the people that actually operating a facility like a manufacturing facility in Stevenage are not people you can hire at this point from the market. They do not actually exist you have to actually trained them.
Actually creating a highly trained and motivated workforce is absolutely critical and one of the key things that we do is actually establish a full fledged training program to make sure that our operators are fully trained fully capable and skilled to deliver this type of.
Of an operation of this type of an outcome.
The culture of continuous improvement is extremely important if you have processes that are has a large number of steps that give you opportunity to improve frankly every single one of them and that ultimately will translate not only in robustness, but also in increased efficiency and with that continued ability to <unk>.
Decreased cost of goods over time, as well as reduce turnaround time and.
Extremely robust and reliable equipment, and a really kind of the the workforce frankly on which we do the manufacturer you can see actually on the lower part of the chart to see the looking at the actual manufacturing success rate the transduction efficiency bank to delivery time, and what we chose two l's as part of the <unk>.
Presentation.
And he would shake you show up every single match manufacturer.
<unk>.
That is important because this is an area, where I think confidence in the manufacturing and the consistency is extremely important that's why we chose to present the data in this quite unusual way.
Field.
Moving to slide 20, just a brief word on the manufacturing facility that commercial manufacturing facility.
We're we're on track to wrong I can take your nomination off this facility.
It was a very unusual project, we built this product or project in record time, we went from ground breaking in November 21 to get the first clean room up and running in November 2002.
And we expect to file.
By the end of this year, so roughly from groundbreaking <unk> filing the timeline of 24 months.
And that includes all the bills.
The full validation of the facility.
And getting all of that obviously into.
Into shape. So that you can actually submit for registration. So it's been a remarkable project, there's a lot of different things.
Areas that we've done quite differently than what is normally done, but I think what it ultimately grits just too is it goes back to the team the ability the goal setting, but as you can see also on the right hand side, what's really important to stay in actually to demonstrate that this type of facility operate in high level of frequency.
Please do that without.
On either equipment on the infrastructure B, a pressure temperature et cetera, or just on the flow of materials goods and people through the facility.
So what you see on the right answer it is actually a capacity challenge we conducted in the second quarter.
Literally every one of the prodigy machines running in parallel.
At that point in time in the facility, which obviously leads us to maximal use Maxwell in either people.
The roof maximal flow pressure on flow et cetera on the tables et cetera facility and really gives you the ability to pressure test identify where you have issues or stress in the system and then actually address that and keep the proofing from there. So it's been a very successful operations that we have in the final park comment I'd like.
To make here is that obviously I arrange delivery time.
Through all the challenges electricity.
21 days.
We expect that to go to after 16 days of lunch and that actually has to do with the commercial operating model that I'll mentioned on the next slide but also.
Set of release assays that actually allow us to accelerating and which are all implemented Android, which meant that as part of the pivotal study and will come to you for effect.
At the time of launch.
So preparing for commercial launch going to slide 22.
There are a number of things that we need to really focus on mommy's, obviously the data at the past approval, which we have talked about already.
Expect to file a BLA.
Application by the end of the year and then early next year for the European side manufacturing also needs to be ready needs to be able to put together and particularly when we then look into the commercial side, we need to obviously have a lot of work or an ongoing on the medical affair side.
Working on the completion of the <unk> at the Central Onboarding, which are really core activities that you need to have in place and and have substantial amount of lead time.
With an obviously a focus in 2024 to really focus on the actual launch prep and execution.
And also obviously considerations around commercialization in Europe .
One of the things that we did report on on Slide 23 is the fact that we have selected Cardinal health is R. U S distribution partner in that.
Is important because it allows us to have some of the commercial infrastructure components to be supported and supplied by our partner.
And that allows us to sort of focus our activities on the specific bespoke aspects of what we need to do.
So distribution obviously.
There is obviously important because the actual way on how these products move or not really moving technically with change of custody.
To a distributor and then all of work, but it goes directly ultimately from us to the center, but they are still has to be obviously, an invoice generate it has to be.
The center has to be checked and make sure that the full everything is fulfilled and it also has to be reporting to the government and those are areas, where cardinal will help us and we will support US same is related to order two cashing activities.
I think what's probably more from an operational and ultimate success perspective.
The depot model wherever you're going to be actually be able to shape.
Or design.
Factor for patients through the U S can actually shifted before they're fully released.
While they're still in our custody moving physically from the UK to the U S.
Get fully released in that time and what soon as to full releases than the product and then actually the move from the depot to the center and that'll.
Obviously allows us some parallel processing and that couch time out of the bank delivery time, which is one of the key contributors to the reduction rates delivery time that I pointed to in my prior slide.
When we look then on slide 24, and 25 is where do we go from here obviously <unk>.
Alright.
Company, obviously, there is quite a lot of opportunity that we see for <unk> that we see it in several directions.
What this slide summarizes is that the way we think about <unk> is not just as a single product.
But it is an actual opportunity franchise.
And that is true for obese sell itself, but also from a lifecycle management perspective actually leading to fall products.
To follow on products are auto 122, which is a dual targeted approach mercy.
Challenge or relax is driven by losses.
And the second is a dual targeting approach for multiple myeloma.
Possibly also for auto immune disease with an approach that has combined <unk> and with a very sensitive fee CMA targeting.
<unk>. So what we've done basically here is were taken the C. D 19 car, which we believe is best in class.
90 dollar individuals from <unk> and we're combining those two additional products with cars that are highly sensitive for CD training to express himself and in fact tailored to actually give us activity against those cells that have very low levels of 22.
Expression as well to make sure that we have a very efficient engagement.
<unk>, even if they're trying to sort of dime modulate CD 22 expression.
Similarly in multiple myeloma manual sells when you analyse patients you can see the expression <unk>.
Extremely low.
10, 2030 receptors or sell thousands <unk> 10, 2030 receptors for sale and that obviously requires a very sensitive marianne to reset it to tackle those cells that make sure they can be efficiently recognize that.
So here the optimization ulcer once upon that's high similar to what brings them <unk> and we're combining both of those cars with a car from of yourself and that gives us a very interesting set of products and it gives us applications. Both on the hematoma oncology side, but also applications that we can choose.
The new plan as well.
We're we're looking to sort of get rid of Cl's Uhm auto reactive.
Detail producing plus myself.
So moving to.
The next slide on this slide 26. This is <unk> seen before summarizing the high speed data coverage at the end of last year.
Saving that data.
Obviously is a very high level of activity with Obi sell EM just as a reminder, <unk>, we're actually dosing patients with a single dose.
And hopefully have.
Very significant level of clinical activity almost all patients achieve metabolic cr's uhm and many of them sustained over extended period of time very interesting obviously, what we're seeing in D. L. D. C. L where we actually see sustained response is center at low relapses, so far which is quite remarkable and also what we're seeing.
Is a good levels of persistence also known Hodgkins lymphoma, which is something that hasn't been quite as consistent across the field.
The safety has been excellent and all of these all of these indications and what belief that the safety profile each with a lot of yourself.
Adaptation savings in those respective indications as well.
Moving to the next slide slide 27 quicker.
A quick word the opportunity to receive <unk> in <unk> disease.
Disease and many.
Many of you have seen the really pioneering work sorry to hear of check in under your smartphone symptoms University of airline.
That was published obviously in several papers and I had it.
That looks at utilizing a C 19 car approach impatience with refractory.
<unk>.
Yeah, I'll come was quite remarkable because what they're basically observe is that the patients lost the auto reactive anti bodies as well as clearly as the underlying producing sales within a very short period of time the antibodies typically got cleared within about a month.
And that clearance actually was sustained over time.
Patients recovered as a consequence of that removal of the order.
<unk> and went from very high composite source to basically baseline.
And these are refractory patients. So the outcome was very remarkable very different from I think anything we've seen in the field based on Monica Lewinsky bodies I mentioned, the fact that around around the Benlysta program. So there's quite a bit of understanding within the comfortably also off all the new diseases to the visa immediately this is a different quality of outcome.
And you've seen a number of companies start to look at that et cetera. We believe we're actually extremely valid position without a coat off because we also do have as far as as far as we can tell that aren't based on data today is that we have the safest and probably the most <unk> in the business. We also have a commercial manufacturing base.
And we have an ability to deliver these products reliably.
Or any of the related <unk>.
We both started out with a those confirmation study will do that.
The patients and we will use that as a basis to discuss the design.
Pillow stuck with the agency.
So that's where we are with the program. We expect to get started early next year and dosing patience and they're really excited obviously the opportunity here.
Just as a quick reminder than on the two other programs that are beyond <unk>.
Franchise I mentioned in order lost money too.
Find a way to mitigate 19 mediated.
I actually lost my Relapses, obviously, we've tested this product to order 122 in patients that are ineligible for Brian including patients that have actually weakness African via therapy with city 19 negative disease and if we can show a very high level of clinical activity that is it gives us a good level of sustained activity as well as an excellent.
Safety profile. So this product obviously is I think doing what we expect it to do and provide sort of an interesting opportunity for investment going forward.
Oh eight is the program.
Targeting multiple myeloma both of that program.
Clinic. Please first date at the end of the year and clearly has to design a design principle that should allow us to kind of details that would be a very low expression of the survey, but also having to see you know I think components and just.
Following obviously the conversation on immunity.
Are both myself that is C. D 19 positive. There is also hypotheses death in fact, those sales with a C. D 19 positive help us out after driving sales and most of my Lola.
<unk> actually the mid nineties Uhm My Doctor Mitsui iPhone Hopkins and that's been one the state that's been going on for awhile and to see if it were belief also with the data we've seen that actually there's a good chance that that actually has an ability to potentially give us sort of a deeper form information.
<unk> and also more sustained presence of the sales that is driven through the <unk> site.
Finally.
The move.
<unk>.
Obviously, we provided an update.
<unk>.
<unk> have seen an excellent combination of the data to keep data really that we were interested in is to see what the complete permission to that we were able to induce in these patients but there were some other time and in fact, we have two of those patients that have crossed while I'm here.
That charged you give us a lot of confidence.
Effects, the clinical effect and benefit that we can actually induce with Sarah therapy, and obviously there is more data that we're sort of working on that we're also looking to publish to data and up here with your journal as well.
Now moving just quickly through the pipeline slide on slide 32, obviously, there is a significant amount of our programs as you can see we do in collaboration.
Collaboration with <unk> program.
Really can be based on clinical data and doesn't have to be based on preclinical data, which we believe and unfortunately in this field do not provide a lot of confidence in terms of the transfer the ability to translate the outcomes into patients.
I would like to hand over to Lucy for the financial results.
Thanks, Christian and good morning, or good afternoon to everyone. It's my pleasure to review on financial results for the second quarter ended June 13th 2023.
Cash and cash equivalents unrestricted cash at June 30th 2023, two $307.8 million this complaint to cashing cash equivalents unrestricted cash.
<unk> $2.8 million <unk> 2022.
Net potential next operating expenses and three months ended June 13th 2023, with $47.9 million as compared to <unk> net <unk>.
$6.5 million.
<unk> <unk> <unk> <unk>.
Research and development expenses decreased by $1.5 million $96.7 million to three months and 18th 19th 23 from digit $8.2 million for the three months <unk>. Thank you switch switch to primary G T. Following.
A decrease of $5.9 million in clinical cause I'm gonna actually comes primarily related to <unk> <unk>.
Decrease the point $6 million in legal fees and potential consulting fees in relation to alrighty activities.
Decreased $2.5 million, the depreciation and amortization 19, <unk> and equipment any tangible assets.
Decreased <unk> $1 million in materials transportation costs.
Israel upset by an increase of three minutes <unk>. Thanks compensation extension, which was mainly driven by an increase in the number of employees engaged 90 activities.
An increase of $1.7 billion in <unk>, Tennessee, the nucleus, which you COVID-19 Steven issue K.
<unk> to maintaining our current lease properties, an increase of point $9 million 92 on T infrastructure and support for information systems, which makes it comes out to his clinical trials.
Operations.
General and administrative expenses increased by $2.8 million to $11.1 million to three months in between Sanchez twenty-three from $8.3 million the same to me to <unk>.
This is primarily due to the following and.
An increase of $1.5 million information witness close to to increase commercial.
Tennessee, staying undertaken an increase of $1.2 million <unk> appointment for 90 constant <unk>. Thanks compensation expenses, which is 99 increase in the number of employees engaged in TNA activities any <unk> any dollars related to I T prescription saputra information systems, <unk> information and increasing.
<unk> $1 million with depreciation and amortization relates to property and equipment any tangible assets and these will decrease point $2 million, primarily the 19 <unk>.
<unk> notices liability insurance premiums legal and professional.
Professional fees.
On the income <unk> increase to income a point $5 million to three months and it changed since you're twenty-three from an expensive $1.3 million for the Saint <unk>, respectively.
The increase of $1.8 million is primarily due to the strengthening of the pounds Stephanie change my email is <unk> <unk>.
The three months ended gene tension 23 that is three months <unk> 1922.
Interest income increased to $3.4 million has been three months and 18th century 23 as compared to <unk> in 2022.
Increase in interest income and $3.3 million, primarily relates to increase the account balances and healed associated without cash and cash equivalents, James three months and get your intention twenty-three to paint the same <unk>.
Interest expense increased to five to $8 for the three months and you change that she's 23 as compared to $1.8 million three months and 18th 2022 interest expense is primarily related to some identity 62, grilled cheeses sound small things.
Change in N out strategic cooperation agreement with Pakistan.
Income tax benefit decreased my full name dollars to $3.5 million for three months and you change essentially twenty-three from $7.5 billion for three months in between sessions 22 due to decreased include fine alrighty expenses and a reduction in effective tax rate <unk> E. K resent she didn't want me tax credit.
<unk> under the scheme to any.
Net loss attributable to ordinary shareholders was pushy $5.6 million to three months and 18th 1923 compared to $42.1 billion for the same thing we did 20 T.
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26 cents compared to basic <unk> lost <unk> and 46 cents for the three months and at June 30th 2022.
<unk> estimates that his current cash and cash equivalents on hand, and anticipate the future most time payments Blackstone will extend the companies from my <unk> 2025.
So before I have that too Christian I wanted to say, what a pleasure it seemed to work with <unk> with a very special thanks to my team and the management team I wish them and the company empty success and she Christian.
Well, thanks, Lucy and thanks in particular for all the contributions over the last few years, you will definitely be missed and I wish you success with with your next steps.
Welcome Rob we're in a fantastic situation that with <unk>.
We have a great successor to Lucy and the role of CFO and I would just like to briefly introduce rock and it also <unk>.
<unk> grow up to introduce himself.
As well so first off obviously as I mentioned earlier that <unk> and check my pharmaceuticals.
In fact, Bob brings a very unusual combination of financial experience, but also operational experience, including deep understanding of manufacturing commercial aspects loss related issues et cetera, which are really important in wherever you are now and I think we'll set us up very well for the next steps that we're gonna take.
The company I think will help us drive to strategy planning execution as well as the next.
Next steps and expansions.
Looking forward to ask we're sort of taking a reception and getting becoming a commercial entity. So with that I'd like to hand over to Ralph just to ask you a <unk> to introduce herself directly.
Thank you Christian and good morning or afternoon to everyone.
I'm delighted to be joining joining a auto is it such an important time with the upcoming <unk> filing.
The expansion of the manufacturing and commercial efforts, it's going to be a very busy time and I certainly look forward to interacting with our analysts and investors over the coming months.
Okay, I'll hang things back to Christian to wrap up with a brief outlook unexpected milestones back to your question.
Thanks, Rob so to summarize and we're moving to slide 36, we think we have an exciting time ahead of US a key focus obviously is getting O b cell into the regulatory process and review.
Just waited a primary focus of the organization.
We expect to be at a filing towards the end of the year followed by a filing in Europe .
In the early part of next year next up obviously are the plant Felix date of presentations at Ash shall we submitted as indicated a few abstract and also we're looking forward to also providing you update it more insights in this study in addition drops of preparing for commercial product supply and launch.
Readiness as a very significant work stream associated with that and we also expect to provide updates on the pipeline programs with additional data and follow up during the year with our key programs, which at this point I will stay on part and it also gives us opportunity for conversations on that side.
Moving to slide 37.
Mm.
We believe are at very attractive and interesting point with the company was taken a significant amount of risk out of the program with a successful data presentations for the Felix study.
At <unk> and <unk>.
And I think that puts us into a position where we believe we have an opportunity to go through a fundamental value step with the the program and thus the famous and obviously, we're looking forward to really driving this program through that process and hopefully onto the market with it I think a very strong belief.
South Dakota has an ability to be transformational for a very challenging.
Challenging indication and I think patients that desperately need access to safer.
Uhm alongside those opportunities that we have an a O L and that were opposite driving with a lot of focus.
As indicated at today's call with C <unk> opportunity substantially broader and we see it as a franchise opportunity that gives us access to arrange a indications with a program overtime and then expanding into the additional related programs with older 122, an auto aid as well so with that I'd like.
To stop here and looking forward to your questions. Thank you.
We will now conduct a question and answer session. Given the time left in the conference. If we don't get to your question, we apologize in advance, but please rest assured management will follow up directly.
Our first question comes from the lineup, Matt Phillips at William Blair, Matt Your line is open.
Hello, Thanks for taking my questions and all the update Christian S. L. We study just curious if you can say at this point a field test multiple multiple dose levels, how the dose my compare to Felix indication do you think there's any reason to look at different Lymphodepletion Regiment and just real quick any.
Data on the Felix M. R. D cohort just given some real world data with the card assertion a lot of use in patients who are already negative. Thank you.
Excellent question, So first off I'm actually.
Clearly, we believe that for the <unk> indications of dose that we need and that indication substantially lower than what we for the.
The last name and your patience.
The mind itself it has to be removed is very very different.
And we expect to be able to confirm eight oz studies substantially lower into syndication, we don't expect to a a dose escalation, but I think we will pick of those within the ability to escalated the installation that become necessary, but we actually do not expect that that actually will be necessary.
So so if we think we're pretty clear what those needs to be.
They don't want to have that confirmed and a small number of patients. So that we have a basis for conversations with regulators for the design of future studies.
We don't think there's a change that we wanted to play around with Luke depletion you could do that.
There is I think we've seen a lot of work that went into the condition and <unk>.
What would that work comes from the original work a stem cell transplant.
For the cell therapies and <unk>. There's a good reason why we have a good level of consensus utilized across a wide range of indication of progress I do not believe the desk area Wanna go back and reevaluate that would take substantial amount of time, I booted hopefully benefit actually <unk>.
Investments.
Where do you go actually M. R D. As in the area of the cough is a reactivate will certainly provided update about certain patients and I'm occupation, which is an obvious thing to look at the coast clearlake patients with lower disease burden have uhm, obviously less work practice for the car T cells to accomplish but also it will help.
To further improve the Oh it always is very very attractive safety profile of a program and should also allow us to consider at least patients with low disease burden patient.
Patients who are in relatively good shape.
To consider those same patients.
Okay, hospitalizations, as well, which I think will further I think support axis facilitate access to.
To I hope you spend lots of therapy.
Thank you please stand by for our next question.
Hi, guys. Good morning, and thanks for taking my questions I want to build on match previous question on S. L. Lee can you tell us how long the dose.
With with with the influence of icons and that's that's very predictive and probably very useful in the physician Hans Uhm. We also know adult yellows rapidly progressing disease. So I'm wondering what your savings that's five days from the <unk> time on Felix.
So what are the good question <unk> first off the question related to the Phase One study design at the D O T period.
Relatively compact D O T period in their hands are using.
So that's something that we're looking into but it's it's clearly also <unk>.
From our experience today is that with an H L. So we have a lot of safety experience with a <unk> with a call back.
The.
The question then related to <unk> aspect and how to activate the impacted by the delivery time, but first of all I think short of answer delivery time always H because the disease can be quite explosive growth. So anytime you shed.
Go off between frankly identifying notation for your patience is going to be helpful. But I think what is really important to you is that you want to actually make sure ultimately that if you're not running the patience to or waited with the patience until this actually reached very very high levels of <unk>.
Before you actually uhm.
All of them for.
For therapy with a heartbeat, that's not a good idea. It's also what can happen at the beauty of the data you step of highly access across the entire range.
I'm off to a Burton and disease state and severity of disease, which is also gives us an awful lot of call here.
Samantha program, but just for very practical perspective, if you have an opportunity to identify the patients earlier and the patient <unk> patient.
To avert and based on that a P. R.
<unk> or N G S.
That actually gives me an opportunity to identify the return policy earlier and that actually increases your chances of a successful therapy at all subtleties inability to move your lifestyle.
So it's clearly and asked if you look at it the same shorter banks delivery time overall helps also because a lot of these patients are very even suppressed there's always a risk that the patients could actually picked up an infection.
The dosage.
That sounds terrible.
Terrible before you <unk>.
So speed is helpful. I think we're at an excellent spot in terms of your time.
Alright, Thanks for taking my question.
Jessica.
Thank you very much one moment for our next call.
Next call comes from the line of Kelly She at Jefferies. Your line is open.
Thank you for taking my questions I have two quick one uhm.
The first name regarding chemicals, and now that I think that <unk>, what kind of expectations has tried to vacation you're gonna need to spell that vanilla shake.
And also what is the maintenance.
<unk> transplant.
I'm not sure.
Thank you.
Larger studies that actually have been conducted.
Interior is one of the largest studies conducted an electric factory patients. So we have a very rich datasets and that allows us to look at aspects in more detail uhm of impact of tumor burden impact of risk parameters.
I can't <unk> and those are clearly key areas of focus that works at a local expect them to provide updates on it. So it's a very rich dataset, what we see that <unk> just scratching the surface of the data that was collected.
I'm looking for.
It'd be so much more details use which also I think.
The data that we have <unk>.
Last few months.
The patients that we had it the study 30% of the patients did receive a stem cell transplant that is pretty much out of the range is <unk> based on clinical practice I think if you.
Have a patient as an example, you have a patient with the younger patients still relatively fit that has an ability or capacity to actually alright.
Stem cell transplant or may not have had one before I think in those cases started with it until he has long term follow up in the study I think physicians will have to make a choice whether or not to fall.
The patient and follow the persistence.
<unk> as indicators for continued pressure on <unk> or if if they think they have a good match with a patient and have to make a decision whether or not the potential to transfer. This is truly a physician decision as you can see is a low percentage of patients.
Actually it was a decision that was chosen to be taken.
But it is clearly one of the options that is available to physicians that is very much a very specific and very.
Detailed analyses physicians.
Like it for the particular patients on whether or not to considerate of transfer and what we also certainly did see in the UK also where the physicians have more experience what is the product and the longer experience with the product is that while the first patient on the old car shows with a C for stem cell transplant actually that.
Use a transplant decrease quite a bit after that.
In patients that actually works as pass it surfing early finding suggests that the patient Unfortunately didn't do any better and so that's all she wanted the key questions as well as whether you need it's beneficial because one of the things you do when you move a patient to trash kind of after Churchy therapy issues. You also get unlimited all the coffee sales prior to the.
That you do have palpitations related to the second transferred including treatment.
So it's a very it's a much more nuanced conversation I think as we have more data and a large or a follow up study I think that certainly area, we're going to look into whether or not patients that have received a second second traveling have received the transplant. After <unk>, how they're doing it whether they actually are doing better or worse.
That patients who did not receive it.
Is that helpful. Thank you and I also have one quick one regarding number this trial, sometimes the manufacturing place that you require additional staff. Please can I can confirm your account I'm, calling I can practice pregnant.
That's a really good question Kelly and.
The answer is actually the lupus patients or a lot simpler to manufacture because you do not have the contamination by high levels of leukemic cells floating at the block. So the starting material you collect for these patients is much better starting with you and it's also because of that you said also little lavish actually.
A short in the manufacturing process for these patients because we need we need.
<unk>, we actually have a much better much more homogeneous sorry material. So it's actually just the other way round is easier to work with.
And what we've done the right amount, which is probably the single most challenging patient population from production perspective.
Thank you.
Thank you very much please stand by for our final question.
Please remember that management will follow up with everyone directly who didn't get to ask the questions.
Our next question comes from Eric Joseph J P. Morgan Your line is open.
We were wondering regarding the S. L. A trial, what clinical parameters and inform an optimal does selection.
Thanks.
Thanks for joining really good question. So what did you want to see is the two two parameters that you'd like to to see and that's I think.
Can actually get out of this this study the first one is you Wanna see that the therapy at the level of <unk> escapes you.
For five G celebration removal of details in these patients at a rapid decline of all the way to <unk> an application and then you also wanted to see that.
Lupus related composite scores actually track down and say, okay. What you would expect most of those to actually go to baseline at the same time, you want to see that that clinical activity can be induce with actually bring any significant level of toxicity to the patient.
So is both to safety that helps you will be important as well as the how can I make parameters as well.
That will be following definitely for.
Shining off of those added activity relationships.
Thank you very much at this time I would not like to turn the conference back over to Christian items for closing remarks.
Well. Thank you very much for joining today I'll say this was a full presentation is a lot of updates that we had.
<unk> I think it's an exciting stage with a company I think it's fair to say, we're kind of moving flat out across.
Across the entire organization to deliver that'd be ready by the end of the year, which requires I'll just say the completion of the work on the manufacturing facility and then also oldie work that's going on on the on the clinical analysis of the house is the clinical data.
From from the Felix study, so an exciting time very.
Very intense but also I think very rewarding because we're feeling that we're.
Working with a product that has a very unusual profile and I think the promise to really have a big impact on patients lifestyle forward, so with that I'd like to thank you all for joining today and looking forward to keeping you updated as we go through the second half of the year. Thank you.
Thank you. This concludes today's conference call. Thank you for participating you may now disconnect.
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