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24th Annual Needham Virtual Healthcare Conference

Apr 9, 2025

Gil Blum
Senior Biotech Analyst, Needham & Company

Good morning, everyone, and thank you for joining me at the third day of the Needham Healthcare Conference. My name is Gil Blum, and I'm a senior biotech analyst here at Needham & Company, covering the immunology and gene therapy subsectors. It is my pleasure to have with me today Christian Itin, the CEO of Autolus. As a reminder, any viewers who are watching through our conference portal are able to submit questions via the Ask a Question box below the video feed window. Christian, I'm actually going to start with a more general question as it relates to your company and how you view the effect of tariffs. I know this was a little bit open-ended, but whatever commentary you have to provide would be helpful.

Christian Itin
CEO, Autolus Therapeutics

Yeah, first of all, thanks for having us in this turbulent time and certainly a time with a lot of change and uncertainty. I think I'll start out with just mentioning that we're obviously entering this phase with a very strong balance sheet, and I think that's important. As we learned, you know, as we went through lots of different disruptive moments, go back to the dot-com crisis, the banking crisis, you went all the way through, in our case, as a U.K. company through Brexit, COVID, and here we are. These events happen. It's very important to be in a strong financial position when you enter these, but also be prepared. There are sort of several layers that I think matter here. I think the first thing is the tariffs themselves.

I think what's important to understand is that obviously different countries have different layers of tariffs right now on a range of products. There's been an exclusion up to maybe today, maybe at another time point of pharmaceuticals. There is certainly a possibility that tariffs may be basically imposed here on pharmaceuticals. What's also interesting to understand is that within pharmaceuticals, there are categories of products that tended to be excluded in tariff schemes in the past. Those products certainly relate to blood-derived products, which actually have been tariff-free pretty much in any tariff scheme ever imposed. I think that's important to remember. Clearly, what we do in the CAR-T therapy space using autologous cells where we collect the cells from the patient, so that's the patient's blood, gets actually transitioned, which is where the GMP process starts.

In this case, if it's a U.S. patient, it starts in the U.S. The cells then get shipped to the U.K., get genetically modified, get released, final release is completed typically when the product actually is in the U.S. and then actually gets returned to the patient. This is a blood product. Also, when you look at the customs regulations, even the ones that were on the web that you could see more than a day ago still would actually describe that blood products, including biotechnologically modified blood products, would be excluded from tariffs.

That is actually what the old regime was. We do not know what the new regime is going to be. We have seen lots of, I think, sets of tariffs that I think were surprising. There were tariffs set on versus countries that had zero tariff on U.S. imports. There were all sorts of, I think, ranges there that were not as easily understandable, probably. What I would take is the position that I think over time, we will see, I think, more of a differentiated view that I think will settle over time.

We do not expect, even if things may be just very simple or very simplistic to start out with, that they're going to actually stay that way. That is kind of the more kind of sort of the more distant view, take a step back, look at this, look at it as a dynamic that we're sort of watching unfold that goes from a pretty crude undifferentiated view to a place that ultimately has to make some level of sense. I think, coming back to where I started, this may take a bit of time.

One of the key elements there, I think, is you have to have the cash buffer to be able to work through that. The second element is that I think it's important to understand when we think about tariffs, what's relevant in that context is customs value. It's not necessarily the product price in the U.S., but it's the customs value. Customs value, there's a set of regulation describes actually how you arrive at that. Typically, not always, but typically that relates to the cost of manufacture. The base actually is probably different than what most people were thinking about to begin with.

That actually allows you to think about it in a way that also, I think, highlights that there's sort of, even if there are tariffs, it's quite likely in many of the scenarios, the impact is going to be somewhat palpable, but it may not be dramatic. That is just something to keep in mind. I think keeping back of our heads that as we're sort of thinking through the changes that might come, that there is actually more differentiation there. There's probably the values that we may think about actually may not necessarily be kind of what really matters here. The third thing that I want to mention is, and this is really an experience both out of Brexit, but also out of the COVID experience, but particularly the Brexit experience.

One of the fundamental problems in Brexit was from the pharmaceuticals perspective and in more general perspective as well is that we had obviously a big risk for disruption at the border because we had a very massive change to the rules that were applied for importation. The problem with that is that whenever you have that, you may not have the manpower. It may be unclear on how to process. The paperwork may not be ready. In this particular case, where we've seen impact on reduction of staff at the FDA, reduction of staff also, or risk of reduction of staff on the customs authorities as well, could actually lead to an aggravation in terms of the ability to process materials at the border.

What we're certainly going to be a lot more focused on than just on tariffs is certainly making sure that we have a good level of processing across the border and that we manage that as closely as possible. That's actually probably the much more imminent risk that I think we're dealing with than the actual monetary risk that a tariff may actually impose. The final point I'd make is what we were seeing, and this was also the experience from Brexit, was that one of the key things that happened during Brexit was that the regulatory authority in the U.K., the MHRA, which had worked very closely with the European Medicines Agency, obviously lost its sort of sister organization because the European Medicines Agency went to Amsterdam. A lot of talented staff went along with it.

As a consequence, there was a very significant understaffing and loss of experience within the regulatory authority. The difficulty that actually that creates is that your regulation stays the same, but your ability to regulate actually is impaired. That actually, I think, is where there's a lot of risk in the process for the industry. I think we had a piece from Janet Woodcock recently where she commented on that and referred to this as one of the risks.

We actually saw this firsthand, the impact from a U.K. perspective. That is probably as much an area to watch out for as I think the risk of tariffs. I'll leave it there, and we're not going to get any political, but this is sort of where I think things that I think are worthwhile keeping in the back of our minds.

Gil Blum
Senior Biotech Analyst, Needham & Company

Maybe to kind of refine your last point, given you are mostly done with regulatory debates in the U.S., how much of an exposure do you have outside of new products?

Christian Itin
CEO, Autolus Therapeutics

First of all, I think we were lucky because we got approved on November 8 last year. We were ahead of all the changes that we've seen since. That obviously was very lucky in timing and puts us in a strong position. The launch is underway. We're in the process of opening centers. We've been beyond 30 at the time of the announcement of the U.K. We keep actually rolling forward. That process is going well, and we're having the support that we need.

For the time being, I think the ability to sort of set up new trials and work with the agency on that has continued to actually work reasonably, but I think there is palpable stress. For the time being, no impact for us, which is good. We're good lucky just from a timing perspective. It is an area that I think we're watching. I think there was much more a general comment for the industry to be mindful about and for investors to be mindful about and maybe also vocal about the importance of a regulator when the regulation actually needs to be applied.

Gil Blum
Senior Biotech Analyst, Needham & Company

Maybe to reorient the conversation around the company and its product, just a quick reminder of your approved product and kind of the overall strategy for Autolus.

Christian Itin
CEO, Autolus Therapeutics

Yeah, so we're sort of at a very interesting transition we're running through. As I mentioned, we got our lead product Aucatzyl approved on November 8 last year. It was the first CAR-T program that got approved without a REMS obligation, which was a reflection of the very positive safety profile that we have seen with the product. What we also did see and were able to do right on the very close to the approval, we got the product also of the data that was underpinning the approval published in the New England Journal. Based on that, we're then able to actually see that the product could get included in the NCCN guidelines.

We managed to sort of get actually included in the NCCN guidelines still in December last year. The importance of that is that at that point, the product becomes a recommended therapy. As you actually start your launch, initially, obviously, your payers do not yet have your brand new product on their policies. It is a case-by-case assessment. For that, it is very important, obviously, to have a recommendation that indeed this is a valid therapy.

The NCCN guideline inclusion was really helpful so that indeed patients could get access and, in fact, the product could be paid for. That was extremely helpful as we started up. Obviously, as I indicated, we had more than 30 centers that were activated at the mid part of March when we communicated the annual results for last year. We keep rolling forward. The 30 centers represent approximately 50%-60% of total patient population access in the U.S. through those centers. It is a very meaningful proportion of the centers already.

We're going to go to 60 centers by the end of the year, which will give us closer to 90% of the patients' access in the U.S. We're well on track on doing that. I think that dynamic's been really supported by the very positive experience that the physicians are making, the centers are making, and obviously the fact that that information and that experience start to spread.

Gil Blum
Senior Biotech Analyst, Needham & Company

I know we were ahead of your quarterly reporting for the first quarter, but is there any additional leading indicators for how the launch is going that you are allowed to provide?

Christian Itin
CEO, Autolus Therapeutics

First of all, obviously, the launch, I think, has gone as well as we could have hoped for as we went through the first quarter. We're going to provide revenue numbers at the Q1 update, which will be towards the middle of May. Obviously, we'll then continue to report, obviously, on open centers or activated centers as well as the actual revenue numbers. We think this is particularly important to sort of be disciplined around that in this space. The reason for that is that there is obviously a time lag between the patients when you identify them, when you start manufacturing from them, until you actually dose them. The revenue gets recognized when the patients have been dosed.

Gil Blum
Senior Biotech Analyst, Needham & Company

Okay?

Christian Itin
CEO, Autolus Therapeutics

That's when you recognize it. It's very tempting to give leading information upfront, but it is also challenging because actually you're basically providing quite often sort of guidance into the following quarter. It is actually kind of challenging to do that because you might actually be confusing in terms of what the trajectory that you might sort of imply with those statements. We've seen that be quite challenging, I think, in terms of those communications for some other cell therapies in the space, and we wouldn't want to do that. We'll stick to the centers that are actually active and the actual revenues that are actually recorded in our financials.

Gil Blum
Senior Biotech Analyst, Needham & Company

We've had quite a few conversations with KOLs in the space specifically for relapsed/refractory ALL in major academic centers, and they've been extremely supportive suggesting that they're considering switching all of their patients. What anecdotal feedback have you had, if any, on your commercial launch?

Christian Itin
CEO, Autolus Therapeutics

First off, I think it was great for you to actually get that feedback because I think that's a very nice way of sort of corroborating and getting a feel for how a product is received. It certainly mirrors kind of what we're seeing and what we're hearing and the interactions we're having. Obviously, we're very close to the centers that we're active in. The way you commercialize these products is actually by providing a series of services to the centers. That is very engaged. It is personal.

It's not just a personalized therapy at the level of the patient, but it's also in terms of the delivery itself. We're very close to the centers, and we're looking to be obviously as helpful as we can be and as supportive as we can be. That's kind of where we are. I think it's sort of what you're articulating kind of mirrors kind of what we're hearing. We're building on that momentum and looking forward to seeing that we can have a very positive impact on patients going forward.

Gil Blum
Senior Biotech Analyst, Needham & Company

What would you say is your largest investment in capital as it relates to the launch?

Christian Itin
CEO, Autolus Therapeutics

Obviously, there's a lot of the investment actually sort of in setting up the infrastructure part. Obviously, a big part of that was the manufacturing infrastructure, the logistics associated with it. That was a major investment, obviously, that and probably the single biggest investment that we made. When we then think on the commercial launch side, it's quite an involved process to actually get the center to the point where the center actually can be accredited. That's a very extended process.

Typically, it takes a few months, can take up to a year, depending on the complexity on the negotiation side of the legal side of the contracts. That's actually a process that's quite involved. That's where I think a significant part of the investment goes in. There is obviously the communication part, medical affairs part, which going forward, obviously, is a key area of activity to sort of create awareness for the product and sort of a shared strong understanding of how to best use the product.

Gil Blum
Senior Biotech Analyst, Needham & Company

Could you also remind us the timelines for approval in Europe and what is your strategy for a U.K. EU launch?

Christian Itin
CEO, Autolus Therapeutics

Right. We did file with the European Medicines Agency at the end of the first quarter last year. We did file in the U.K. in July last year. We are in the process in quite advanced stages of the review process. We would expect that approvals would get through in the second half of this year. Obviously, in any one of the European countries, you also have to go typically through a process to actually secure your price and then actually move forward. That is certainly the case in the U.K., where you go through a price assessment and a value assessment of your product.

That is a very defined process, which we are kind of working through in terms of the value dossiers and the various steps you are going to run through. From a European perspective, our initial focus is going to be on Germany with a goal to sort of be in a position to launch in Germany early next year. It is the approval, and then there is usually a set of additional kind of steps you have to go through. Germany would expect early next year, and the U.K., we are hopeful that we are going to be properly launching the second half of this year.

Gil Blum
Senior Biotech Analyst, Needham & Company

I didn't want to spend a minute also on the product profile itself. Aucatzyl is the first approved CAR-T without a REMS protocol. Just to help people understand what that means in a clinical practice.

Christian Itin
CEO, Autolus Therapeutics

Right. A REMS protocol basically gets included in a label or as an obligation with an approval if you have a particular set of adverse events that you'd like to actually develop a better understanding for in a larger patient number. Typically, REMS programs are set up or certainly were set up in T-cell engaging approaches as well as in CAR-T approaches to better understand the impact and long-term impact of cytokine release syndrome, but also neurological toxicities. We had seen that after, I think it was about 10 years after the launch of Blincyto, the REMS program for Blincyto came to an end. There was enough data collected, enough understanding developed about the consequences of those adverse events. What it basically means for the centers is that you actually have to record these events in a separate database.

Now, a lot of the centers also FACT or JACIE- accredited and actually in the context of those accreditations already collect a lot of that information. They ended up having to sort of basically have two different databases to record information in. In a very practical perspective, it meant a lot of added work or additional work for the centers to actually carry. To be able to actually have a product that actually does not require that extra burden for the centers is obviously very beneficial because all these centers tend to be short-staffed. You want to be able to actually focus the time of your nurses and physicians to be spent helping and managing the patients rather than actually working on administrative tasks.

Gil Blum
Senior Biotech Analyst, Needham & Company

Another feature of the treatment of relapsed/refractory ALL that came up from our conversations with experts is that a lot of times it's used for consolidation, actually almost off...

Christian Itin
CEO, Autolus Therapeutics

Almost off-label?

Gil Blum
Senior Biotech Analyst, Needham & Company

Not exactly off-label, but the physicians have been defining relapse differently. How have you seen this in practice, and how do you think that shifts over time? Are physicians going to look at true refractory patients and more MRD positive patients?

Christian Itin
CEO, Autolus Therapeutics

I'll answer the question from two different perspectives. The first one is the perspective of the label. The label describes relapsed and refractory patients. This is what the label describes, and that's sort of the group of patients that are included. What we have studied in the context of the FELIX study is the majority of the patients were patients that had more than 5% tumor burden at the time of inclusion. We also had a separate cohort that looked at patients that had minimal residual disease or disease burden that was below 5% tumor burden, which was a separate part of the cohort. There was also a group of patients that had isolated extramedullary disease, in essence, a relapse of the disease outside the bone marrow, which happens actually, unfortunately, not infrequently in these patients.

It's typically a sign for a very difficult-to-treat indication or disease. That's what the label describes. Now, clinical practice is that what we've learned with ALL is that the relapse, obviously, tends to start in the marrow. You gradually go through, obviously, the divisions of the tumor cells, and you gradually build more and more mass in the marrow. The original way of determining the tumor burden was actually by microscopy. You literally look at a bone marrow sample, and you count the cells by eye. The blasts you count is basically a morphological signature that you look for.

You can sort of reasonably reliably actually determine 5% of the cells to be of the morphology that you would also associate with the leukemia. That was sort of basically think about it as the resolution by eye that you could actually get to. Now, that means that, of course, there's already a lot of tumor burden in the patients. At that point, if you keep, obviously, going through the rapid cell division cycles, you could go very quickly from 5% or 10% to 90% tumor burden.

At that point, obviously, the patients become incredibly difficult to control. They have a lot of adverse events related to the disease. There is a lot of push in the field to actually go for patients and identify patients that are earlier in their relapse. When you have a lower number of cells, and there are different methods used for that. There is flow cytometry used for that. There are PCR-based methodologies used or NGS methodologies used. They give you sensitivities that go one in 10,000, one in 100,000, one in a million that you can actually cells you can detect.

What we know from all of the data over the last 20 years is that patients that have signs of this early minimal residual disease, so measurements of cells at this very low level, invariably do relapse. It just takes longer because there's more cell divisions to run through. What we also did learn is that if we treat the patients at that point in time, we have a much higher probability of actually getting a long-term outcome because, frankly, there's less cells to kill. There's a higher probability we get them all than if we have a situation where there's 90% of all cells in the marrow are tumor cells, and they're kind of spreading all over the body, and it's kind of hard to get at all of them and get them completely eliminated.

The concept of consolidation is one where you treat with an initial therapy, get to a meaningful response, and then basically have a second step in the treatment that cleans out whatever is left. That is the consolidation. The way that is done typically could be actually in different types of ways. It could be with a stem cell transplant, or it could be with a T-cell engager or an ADC or a CAR-T. That is a modality that is used quite a lot, and I think it has been very successful, particularly in a frontline setting where you had initially removed the tumor and then consolidate. As we have the product approved today, our label does not include frontline consolidation. That is not what it is.

There is a lot of interest to explore that in investigator-sponsored studies, and we're looking forward to seeing some of those studies, I think, get off the ground, hopefully by the end of this year and then onwards to start exploring the opportunity here and the ability of our product, which has shown extremely high levels of activity and ability to deliver long-term outcomes in patients that have low disease burden. That's the patients that actually have the highest probability of long-term outcome and actually use that principle and start exploring that, at least initially in investigator-sponsored studies in the frontline setting. It is the trajectory, I think, that ultimately we'd like to see the product go. There is certainly a lot of interest to explore that in sort of a controlled setting.

Gil Blum
Senior Biotech Analyst, Needham & Company

Excellent. I don't want to spend a significant portion of the rest of our time here on the autoimmune portion of the story, given that the results are coming up soon. Maybe a good place to start, it's a pretty competitive environment, quite a few of these out there. What gives you confidence that Aucatzyl has a better profile and chance of success here?

Christian Itin
CEO, Autolus Therapeutics

One of the things that obviously is very attractive from our perspective is the fact that we're operating with a product that has achieved an approval. None of the products currently in evaluation actually have achieved approval anywhere else. We are the only approved product that actually is being evaluated in these approaches. That is the first observation. The importance of that is not only that there is a lot of safety data available, but we also do know that we have a remarkable profile from an efficacy perspective, extremely deep responses that we could obviously evaluate with very, very sensitive methods in ALL combined with an attractive safety profile.

I think both of those matter because you need a deep cut in the compartment to actually get to a place where you hopefully get to a long-term outcome in autoimmune disease and have sort of a reset. On the other hand, you need to actually have a safe product because clearly these patients have a lot of comorbidities as well. These are not oncology patients, and they're typically not treated in an environment quite as what we're used to in the hematology setting. It starts with actually this is a product that has a real reality, has a label, has a production base, is commercially present.

Obviously, what stands out for the product is that when we look at patients that either have low disease burden in ALL or have non-Hodgkin's lymphoma, the patients do have a very good safety profile. They didn't have high-grade CRS, and they had no neurological toxicities. That's a great profile to start out with. That's the starting point. We're evaluating now the product in patients with SLE, and we're going to treat those patients with a fixed dose of 50 million cells. That is basically derived from the dose that we're using in children in pediatric ALL.

That also was the rationale and the way that the original data was generated at the University of Erlangen in the space was also actually delineating their dose finding. They started with a product that they used in pediatric patients. We compared our data actually to their data, and obviously do have a very attractive profile also compared to their product. Actually, obviously, in kids having a body weight-based dosing because you have a wide range of very young kids up to obviously very large kids with very large bodies. You need variability there, but in an adult treatment, you don't want that. You want simplicity.

You want a single dose. You want a dose. You just do not have to actually go out and calculate what you should be using. This is the rationale for the fixed dose, which is also true, obviously, for what we are using for the adult patients as well, which is also fixed dose. We are going to evaluate that, and we are going to be presenting kind of a first view of that data, initial data at our R&D event on the 23rd of April in New York. Obviously, opportunity to join us there at the Yale Club as well as look at the data and get an understanding of where we are headed through the webcast as well.

Gil Blum
Senior Biotech Analyst, Needham & Company

Okay. Maybe focusing on this first look at the data for the investors in the crowd, what should they be expecting, number of patients, follow-up, that sort of thing?

Christian Itin
CEO, Autolus Therapeutics

Right. The initial cohort is six patients, 50 million cell dose, all dosed. We're going to have obviously varying degrees of follow-up. We have a few months or more than six months in one patient. We had two or three patients at a range of about three months plus of follow-up, and then we have patients that are just beyond one month at this point in time. What we can see and what we'll be able to look at is actually first the behavior of the product. That's kind of the expansion of the product, the persistence, which gives us, I think, a very good feel for the consistency of the product. The second area is, of course, adverse events. We've seen quite frequently in those patients with other programs, CRS or even ICANS. I think safety signals do matter.

We can obviously look at readouts for pharmacodynamic markers as well as clinical markers in these patients and how they fare over time. I think it will give a good impression, a good feel for what the product profile is. One of the key things that we are looking to do is actually discuss the path forward and the opportunity here to really move to a potential pivotal study, which I think is going to be important. I think we will give direction as well as address, I think, sort of an idea around timelines, et cetera, as well. What we want to do and embed this in is really articulating, have external speakers who will talk about what good looks like in those respective indications, which has been a real challenge.

I think for a lot of people, it's been a challenge for us being hematologists, most of the background that we have within the company. What does good look like in these settings? I think that should be helpful also for investors and analysts. Obviously, also have an ability to sort of get a better understanding of the actual medical need and what does it mean for these patients and what are the right patients to think about using this type of a therapeutic modality. Those are kind of the areas of focus for the meeting and those that we're looking forward to seeing, hopefully, many of you at that event.

Gil Blum
Senior Biotech Analyst, Needham & Company

Maybe I'm preempting with this next question. Where do you view the main market potential for a product like yours?

Christian Itin
CEO, Autolus Therapeutics

The way I would look at it is, first of all, the product, I think, has multiple opportunities from an indication perspective, both obviously in the hematology space as well as the autoimmune space. When I think more specifically about the autoimmune space, I think what's attractive about it is areas where you have a high medical need, a pretty big risk that a patient may have an organ impairment over some period of time and a shortened overall survival as a consequence of that. I think that's clearly where we would like to focus on. We're looking at the sort of more refractory type of patients, obviously patients that still have evidence of an inflammatory process that's ongoing.

I think that's sort of the sweet spot, I think, that you'd be looking for in any of the autoimmune indications you might think about. Those are kind of the key areas, I think, and key kind of elements of focus that I think we want to sort of look at. The opportunity, I think, in each one of those is pretty significant because if you're looking at even in SLE or lupus nephritis, that complex, I mean, you start with about a total of about 400,000 patients in the U.S. Even if you start with that and you go to the refractory population, you're still talking about 20, maybe 30,000 patients.

It is still very sizable, very meaningful, and an opportunity to have a meaningful impact, obviously, for these patients, which have very dire outlook otherwise. I think that's kind of the opportunity there. When I think about the opportunity on the hematology side, I think it's really focused on driving long-term outcomes for patients and ultimately increased cure rates. I think that has to be the focus of this type of a therapy and the positioning of the therapy as well. This is obviously clearly what drove us in ALL, but it's also applicable outside of ALL.

Gil Blum
Senior Biotech Analyst, Needham & Company

Another comment that we've heard from a lot of our companies in the cell therapy autoimmune space is enrollment challenges, both from competing programs, but also just the logistics of getting oncologists and rheumatologists to talk to each other. How have you guys been circumventing these challenges?

Christian Itin
CEO, Autolus Therapeutics

Yeah. I mean, any new modality that you introduce into an area like rheumatology has sort of an inertia initially. I think that's part of what you're hearing from those commentaries. I think what's important for us and what's obviously sort of a really helpful starting point is that we're going to be in the U.S., we're going to be present in most of the relevant centers, commercially present. The product actually is known to the hematologist. There's experience with the product. I think that's an important part because it means that there are physicians who can talk about their own experience with the product when they talk to their colleagues on the rheumatology side, and they're also talking to patients.

I think that confidence, that experience, that confidence, knowing the commercial product, I think is going to be really important. The second step, as you point out, is that as we're sort of thinking about conducting these clinical trials, it's really a collaboration between the rheumatologists who are caring for these patients and the hematologists that deliver the therapy. You need to foster a collaboration between the two. That is really important to do. We've seen that as soon as that started to sort of occur, actually, you got a very nice momentum in the study.

I think that's obviously one of the nice things about where we are with the product and being present in a large number of centers in the U.S., across the U.S., and also in the U.K. as well, and preparing in Germany as well, gives us a foundation, which is obviously very nicely differentiated and I think allows us to build on that experience and enthusiasm from the hematologists to then actually rub off on the rheumatologists and also, frankly, give reassurance to the patients for this very different type of therapy.

Gil Blum
Senior Biotech Analyst, Needham & Company

We only have a few more minutes left, so I'll remind the audience so they can write in a question if they have one. I do want to ask at least another one on the commercial manufacturing. What do you consider the key challenge, if any, in your manufacturing supply chain?

Christian Itin
CEO, Autolus Therapeutics

I think one of the things that is obviously very interesting is when you're in this space is that different from any other therapeutic modality, you don't start with an inventory. Because normally you start with an inventory, you have a year's worth of material drug supply you can deliver. Actually, drug supply is reasonably relaxed because it's dissociated from the treatment of the patients. What's very different here is actually your first patient that signs on, that gets apheresed, that's when your factory starts actually running. That's when you get everything in motion. Up to that point, you're prepared. At that point, you start running. What's been very interesting is obviously kind of just to start up and get into the steady rhythm, give you a flavor.

The operation that we're running is a two-shift operation, seven days a week. It's a real industrial process. At this point, we're at a place where, frankly, these processes are humming and are running, obviously, as you would hope for. As you can imagine, the first few weeks getting to that state where things are starting to run smoothly, obviously, takes a few steps. We're at a great place now, and the team's doing a fantastic job actually supplying. It's definitely one of the important things is having made that investment in people, in infrastructure, and capabilities that I think is absolutely critical for us to execute.

Gil Blum
Senior Biotech Analyst, Needham & Company

I do want to end with what you kind of started with, just to remind everyone of the company's cash position and runway.

Christian Itin
CEO, Autolus Therapeutics

Yeah. Obviously, we're a good way north of $500 million in cash with the company. That gives us, obviously, an ability to, I think, get through a pretty turbulent type of period that I think we're going through. We're obviously starting to generate revenue. We'll give you a first number at our Q1 report coming up in May. That obviously is going to be a key element here in terms of the overall cash position of the company going forward. I think we'll start to give, I think, a good sense of how this is actually moving. I think we're in a great spot and looking forward to keeping you updated and are looking forward to deliver really important outcomes for patients here.

Gil Blum
Senior Biotech Analyst, Needham & Company

Maybe as a last, last message, turbulent times in the capital markets. What is your message to investors who are probably pretty frenetic right now?

Christian Itin
CEO, Autolus Therapeutics

First of all, I think I'm not going to tell you what you need to do because, frankly, that's the business that you guys are all in. You know a lot more about it. What I just know coming looking at it from the operating side is, on the one hand, you want to be prepared, but you also don't want to be rash. You want to understand your options.

I think in a lot of downturns and a lot of asymmetric situations that I think we have given on a lot of the SMID- cap names, where there's a lot more upside than there is downside and a lot of companies as ours sitting on a lot of cash, I think there is also great demand of opportunity here. I think one to navigate, and it'll be interesting. I'm pretty sure there's going to be people who make some courageous calls and are going to do really well out of this environment that we're currently in.

Gil Blum
Senior Biotech Analyst, Needham & Company

Excellent. Thank you very much for attending today, Christian.

Christian Itin
CEO, Autolus Therapeutics

Thank you very much. Much appreciated having us.

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