Adaptimmune Therapeutics Q1 2024 Earnings Call Transcript

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May 15, 2024

There are 15 speakers on the call.

Operator

Good morning, ladies and gentlemen, and welcome to the Adaptimmune Q1 2024 Financial and Business Update Conference Call. I would now like to turn the meeting over to Ms. Julie Miller. Please go ahead, Ms. Miller.

Speaker 1

Good morning, and welcome to our conference call to discuss our Q1 2024 financial results and business updates. I would ask you to review the full text of our forward looking statements from this morning's press release. We anticipate making projections during this call and actual results could differ materially due to several factors, including those outlined in our latest filings with the SEC. Adrian Rawcliffe, our Chief Executive Officer is here with me for the prepared portion of the call and other members of our management team will be available for Q and A. With that, I'll turn the call over to Adrian.

Speaker 1

Ad?

Speaker 2

Thanks, Judy, and thanks everyone for joining us for our Q1 call. I plan to provide some brief comments before we go into Q and A. The comments are going to be brief because a couple of weeks ago we held an Investor Day and we provided a fairly comprehensive update on the regulatory status of Afamisal as we move towards the PDUFA date of the 4th August. And we also talked about how important this is for the field as the first approved engineered TCR T cell therapy for a solid tumor indication. We also discussed our preparations for the commercial launch of Afamicel in some detail.

Speaker 2

We said that we'd be ready to do this on approval of Afamicel and that this would be the beginning of a commercial sarcoma franchise that we feel has significant and underappreciated value. In this morning's press release, we provided a further update on the BLA progress and our Head of Late Stage Development, Dennis Williams is here for the Q and A portion of this call. In short, our interactions with the FDA are progressing as planned and we're looking forward to our late cycle review meeting in the second half of this month. Thus far, the FDA has not requested an ADCOM or a REMS program. We look forward to the labeling discussions and also to commercialization in due course.

Speaker 2

And I'm happy to confirm that our customer facing commercial and Medifares team are now fully in place. Cynthia Pacino, our Chief Commercial Officer is here for the Q and A as well. As I said, we are on track to be ready to launch on approval. We have a focused team starting at 6 to 10 treatment centers and ramping up to approximately 30 in due course. And if you revisit the Investor Day presentation by Doctor.

Speaker 2

Mihael Latruta, which is available on our website, you will see that the expectations and anticipation for a famicel within the sarcoma community are very high. I think that sense of anticipation was reinforced by Philip Leeder, patient advocate and President of the Sarcoma Alliance, who lost his sister to sarcoma. And he, I think, very eloquently highlighted the demand for novel therapies in this space. So we are scaling our manufacturing to be able to meet what we anticipate to be the launch volumes for Afamucel in the second half of twenty twenty four. And in summary, all is on track for the launch of a famicel on approval.

Speaker 2

And that's expected around our PDUFA date in August and is highly anticipated by the sarcoma community. And obviously, we are very eager to get this product into the hands of this community that has worked so hard with us over the last decade to develop medicines for sarcoma. Behind the Famicel, we are also progressing the development of Letiselle and I'll point you towards a presentation of the interim data analysis from the pivotal IGNITE ESO trial in synovial sarcoma and MRCLS that we previewed at a high level last year. These data look very similar to a famicel other than of course they are in both synovial sarcoma and myxoid rounds of liposarcoma. And that will be presented at a platform presentation at ASCO by Doctor.

Speaker 2

Sandra D'Angelo. This will be an important milestone for people's understanding and the de risking of this cell therapy As we continue to move towards having a BLA in place in 2025 with anticipated approval for lekicel in synovial sarcoma and MRCLS in 2026. You will have seen another press release from this morning announcing that we've secured up to $125,000,000 in debt financing with Hercules Capital with the first tranche of $25,000,000 available on closing and an additional $25,000,000 available on abamisal approval. In addition, you will have seen that in Q1, we raised approximately $30,000,000 off the ATM based on significant inbound inquiries. We've taken these steps to secure our financial position and have cash runway into late 2025.

Speaker 2

And with this runway, we have the funds necessary to execute on our priorities. The launch of Afamucel, followed by Letiselle and also executing on the other pipeline projects such as the Phase 2 trial with UZACEL for platinum resistant ovarian cancer. And Gavin Wood, our Chief Financial Officer is here for

Speaker 3

the Q and A as well.

Speaker 2

So with that, I'd like to turn it over to the operator for questions. Operator?

Operator

Thank you. We will now take questions from the telephone Our first question is from Jonathan Chang from Leerink Partners. Please go ahead.

Speaker 4

Hi, guys. Thanks for taking my questions. First question, can you talk about the impact of the debt agreement announced today on your cash runway guidance? I'm just trying to better understand what's assumed in the current guidance.

Speaker 2

Gavin? Yes.

Speaker 5

Hi, Jonathan. So a number of things have changed since we last gave guidance at the start of the year. Clearly, we had the termination of the Genentech agreement and we're still working through the terms of that termination agreement. We've made significant progress on Famicel and the broader development of the broader sarcoma franchise. As Ad just mentioned, we've raised money under the ATM and we've also executed the new debt facility at Hercules.

Speaker 5

Putting all those moving pieces together, we thought it prudent bringing our cash runway by about a quarter to late 2025.

Speaker 4

Got it. And what assumptions are there for how much of the debt is being drawn down?

Speaker 5

We drew down $25,000,000 closed and there's $25,000,000 available at the PDUFA date.

Speaker 4

Got it. And then second question, just can you help set expectations for the upcoming ASCO Ignite EASO presentation? Thank you.

Speaker 2

Dennis, do you want to take that?

Speaker 6

Yes, sure. So, for the ASCO presentation, we're going to be presenting results on the interim analysis of the pivotal IGNITE EASO trial. So this is 45 patients in that trial followed for at least 6 months. It's evenly comprised of patients with synovial sarcoma and mixed with ground cell liposarcoma. So we'll present the efficacy data and safety data that were available at that interim analysis.

Speaker 4

Got it. Thanks for taking my questions.

Speaker 2

Thank you.

Operator

Our following question is from Mark Fromm from TD Cowen. Please go

Speaker 7

ahead. Hi, thanks for taking my questions. Maybe just first, nice that you're giving these details along the way of the FDA review and the late cycle review meeting coming up. Just can you kind of review what your closure strategy is going to be around some of the information that may be conveyed or gleaned by you guys at that meeting?

Speaker 2

So why don't I take a stab at that? So we're actually running pretty hard towards the both the late cycle review meeting and the discussions on labeling that we anticipate and on post marketing commitments. We're going to be focused on that in the run up to the PDUFA date. And I think if there's anything material that comes out from that, we will be disclosing. Otherwise, we're pushing hard for the discussions with the agency and getting to PDUFA and then being able to launch.

Speaker 7

Okay. And then as you get into the labeling sessions, I mean, what do you view as the kind of major kind of questions that need to be answered about indications and things like and things to include or not include in the label?

Speaker 6

Yes. So, hi, this is Dennis Williams. I think it's like I mentioned at the Investor Day, some of this really comes down to individual sort of wording that goes in the label. Like for example, I'll give the follow-up on the example I gave at Investor Day, how we manage cytokine release syndrome, right? So we'll be talking about how that information should be structured in the label, how we give tocilizumab or how we would recommend that product and for what grade CRS.

Speaker 6

So sometimes it's really about the finer points of how the words are in the label. We have had no discussions to date with the FDA around the indication statement and we feel very confident that the indication statement we proposed is more or less a few words is what we're going to end up with at the end of this review.

Speaker 7

Okay. Thanks. Very helpful.

Speaker 3

Thanks, Mark.

Operator

Thank you. Following question is from Tony Butler from Rodman and Renshaw. Please go ahead.

Speaker 8

Yes, good morning. I'm very respectful of the focus on naphamicel and to a lesser extent on Ledi, but I wanted to ask about uvacel and whether or not, at least in the calendar year, there was any anticipation of a follow-up on SURPASS-three either in ovarian or in the Phase 1 with bladder etcetera? Thanks very much.

Speaker 2

So why don't I cover that with what we're thinking about for Eucercell. With SPAR3 in platinum resistant ovarian cancer, that's designed with the potential to end up as on that until we have at least enrolled all on that until we have at least enrolled all of the patients in that trial. There are interim reads for futility analysis, but we won't be communicating the data until we've at least enrolled all of the patients in that trial, which we anticipate being a 2025 event, full enrollment of that trial. So with respect to the other indications, so we've now focused down on to ovarian cancer in SPASP 3 and the 2 other indications in head and neck and bladder. And the objective is to gather data in a Phase I setting in a range of patients potentially in combination with checkpoint inhibitors as well.

Speaker 2

And what we've said there is we anticipate giving an update on the basis of the data that we've gathered at the tail end of this year about how we anticipate moving forward with those, which would include the data themselves.

Speaker 7

Thanks very much.

Speaker 2

Cheers, Tony.

Operator

Thank you. Our following question is from Craig Souvannavejh from Mizuho Securities. Please go ahead.

Speaker 9

Good morning. Thanks for taking my question and congrats on all the progress. Just wanted to go back to the FDA review process and in particular, also in light of the great analyst event or investor that you had down in Philly. Just curious if there have been any other perhaps progress or maybe any additional inspections by FDA on the manufacturing facilities? Do you expect any other visits prior to approval?

Speaker 9

Just wanted to get a better handle on how things were shaping up there as it relates to CMC manufacturing and your facilities?

Speaker 6

Yes. Hi, this is Dennis Williams again. So yes, I think at this point, all the inspections are expected to be completed, right? So we both manufacturing facilities that we utilize, so our own manufacturing for a Famicel drug product, the lentiviral manufacturing facility that we for the vector that supplies for drug product has been inspected.

Speaker 3

That's had

Speaker 6

a good outcome. And all the clinical trial sites that were inspected also are completed. They all had a very good outcome. And as I mentioned during Investor Day, the AVR facility here from a GCP standpoint was also inspected. So at this point, we think all the inspections are complete.

Speaker 6

I guess there's always a scenario where another clinical site, but could be inspected. But at this point, I think at this stage in the review, the inspections are completed.

Speaker 9

Okay. Thank you for that clarity. And just with regards to earlier comments, the company made about not anticipating or not expecting perhaps an adcom or a REMS program, maybe just on the latter with regards to REMS. Just from a calendar perspective, is it something that a discussion would naturally have happened by now or is it still part of a potential discussion between now and the PDUFA? Thank you.

Speaker 6

Yes, sure. So, we did not submit a REMS in this BLA application. And we've had discussions with the FDA during the review. And I think at the time I had this discussion at Investor Day, the FDA review was ongoing and there was no decision about REMS at that time and they certainly had not asked for one at that time. You're correct that had REMS been requested that that time would have elapsed already, that would have occurred within the few weeks of that mid cycle meeting.

Speaker 6

I can just say, in general, the conversations we've had with the FDA, we don't anticipate a REMS for this product.

Speaker 9

Okay. Thank you. And maybe just the last question if I could. Just if you could remind us all, assuming an on time approval, how we should be thinking about the shape of the uptake curve particularly from a revenue perspective?

Speaker 2

So why don't I touch on that, which is the what we've basically guided to is that we've not given guidance on the specific numbers of patients that we anticipate coming through in the early part of the launch. What we have said is that it's important to understand that because this is an autologous product that's manufactured, need to be screened for targets and then manufactured and then returned to patients. Whatever you think that uptake curve looks like, it's essentially frame shifted by and we're guiding to about a quarter from so the first revenues from a Famicel would the first patients would not be dosed treated and the first revenues recognized until Q4 this year, even though we anticipate approval and we anticipate starting to enroll patients from the PDUFA date in August.

Speaker 9

Okay. Thank you.

Operator

Thank you. Thank you. Following question is from Michael Schmidt from Guggenheim. Please go ahead.

Speaker 8

Hi, this is Paul on

Speaker 10

for Michael. Thanks for taking our question. So on the Athanasil launch, you talked about targeting about 6 to 10 sites for that early launch. But looking beyond this year, what's your current thinking on strategy for scaling up to all 30 ATCs across the country? And how many of those centers have had experience with atamisil in the clinical trial setting?

Speaker 2

I'll ask Cynthia to talk to that. Cynthia?

Speaker 11

Thank you. Yes. So we are, as Adrian said, we are targeting about 6 to 10 sites during the launch period, meaning the Q1 after launch. And we are already starting to engage beyond those with the expectations to have up to the 30 sites available about 18 months after launch. Out of these 30 sites in total, 16 of them, which will be the priority sites, have clinical experience with tafamicell.

Speaker 11

And some additional sites that are part of the study also have experience with leadicel. So all of our 30 HCCs in the future, all of our clinical sites from Letiselle and Afamicel will be part of those 30. And again, we know that those sites see the majority of the synovial sarcoma patients in the country.

Speaker 10

Great. And maybe just a follow-up. As you look ahead to the launch, can you give a sense of what kind of metrics you're planning to sort of disclose in the early months to give a sense of how that launch is progressing? This has been an area of focus for the IMTAPI launch for Iovance. So just curious if we can expect updates on the number of patients identified versus infused or if you're likely to provide more positive updates in the early month?

Speaker 10

Thank you.

Speaker 2

So we plan on updating that at our next Q call.

Speaker 10

Got you. Thanks so much.

Speaker 3

No problem. Thank you.

Operator

Thank you. Our following question is from Arthur Hee from H. C. Wainwright. Please go ahead.

Speaker 12

Hi, Ed and team. This is Arthur from H.

Speaker 9

C. Wainwright. Thanks for taking my question.

Speaker 12

I guess I just had a broad picture question. So as we see the cell therapy industry moving to the autoimmune disease area, could you help educate us the potential from your platform aiming for the autoimmune disease? I know you guys are later focusing on the launch, but just curious on the potential there. Thanks.

Speaker 2

Sure. So as you've said, we are laser focused on the launch. We have, if you dig into the history of the company long enough, we have explored the opportunity to develop TCR targeted therapies for autoimmune disease, mostly focused on Treg programs. But I think in the short term, our focus is on obviously the launch of Afamacel and the sarcoma franchise. But also in between that and the very long term future in autoimmune and maybe other indications, just the massive unmet need that can be addressed with TCR T cell therapies in the oncology space.

Speaker 2

And if you look at the rest of our pipeline, you'll see that as we over the coming years, we will very quickly move from a sarcoma only franchise with 2 products and £400,000,000 of sales into much larger patient populations. And there's an opportunity with UsaCel in obviously ovarian bladder and head and neck. And then beyond that with PRAME, given the recent interesting data with that target and with CD70, both of which are in the late preclinical pipeline. And the opportunity there to address over 100,000 patients that are currently dying from their indications with the right target and the right HLA type. And so when we see this in terms of horizons, short term, sarcoma, longer term broaden that out, making cell therapies potentially curative and mainstream across a broad range of tumors and then taking cell therapies into other spaces where patients could benefit in other non oncology indications in the long term.

Speaker 13

Thanks for the color.

Operator

Thank you. Our last question is from Peter Lawson from Barclays. Please go ahead. Mr. Lawson, your line is open.

Operator

You may proceed with your question.

Speaker 3

Great. Thank you so much. Thanks for taking my question and thanks for the update. I wonder if you could talk around the turnaround time, kind of time it would take between kind of approval, booking the initial revenues, as we can just think about the turnaround time, your end, also the turnaround time with the hospitals and the patients and any variables that we should be thinking about?

Speaker 2

Cynthia, do you want to talk to that?

Speaker 11

Yes, absolutely. Yes, so when we think about the turnaround time from the patient journey perspective, we need to consider that the patients when they are identified, the first step is that they need to be tested for HLA and MAGE A 4, which is a process that can take a few days. Then we go through the apheresis process, scheduling apheresis. And then when we receive the apheresis material from a manufacturing turnaround time, then that would be of about 30 days and then shifting it back to the sites. So that's why at launch, the companion diagnostic test will be approved at the same time that's our expectation at the same time that Afamisel is approved.

Speaker 11

So we would expect that you see, as Adrian mentioned before, 1st patients dosed during the Q4 of the year.

Speaker 7

Got you. Okay.

Speaker 3

Thank you. And then after the patients identified in the apheresis, what's the general timeline you expect around that? I imagine there's a fair amount of variability.

Speaker 14

Yes. Hi, this is John, leading manufacturing. So the turnaround time from typical time from the collection of the apheresis material until the release of the product to send it back to the site tends to range between 4 6

Speaker 3

weeks. Okay. And are there things we should be thinking about the front end and the back end that are outside your control and kind of the sense you get how long it takes patients to kind of get through that funnel from being identified by diagnostic test for HLA? And then the other end, once it gets to hospital and actually gets infused?

Speaker 11

Yes. So a couple of things to consider before will be patient identification, the testing, then depending on where these patients are, they will have to be referred to a treatment center that can take a few days. Reimbursement is also something that will be checked at that very early part of the journey. Then from Afreases all the way back to infusion, it's mostly straightforward. We could have potentially the patient condition getting worse or other things that are out of control, but then it's mostly a little bit more straightforward.

Speaker 3

Got you. Okay. And just I final question just around the SURPASS data. I guess it's later this year we get head, neck and bladder. Just expectations around the number of patients we should see and kind of what you regard as a positive coming out of those datasets?

Speaker 3

Elliot?

Speaker 6

Yes, thanks. We haven't guided to specific numbers that we would anticipate as it relates to patient dosing. We have said that we anticipate having sufficient data to make directional decisions regarding both of those indications by the end of the year.

Speaker 3

Great. Thanks so much.

Speaker 13

Thanks. Thanks, David.

Operator

Thank you. We have no further questions registered at this time. I would now like to turn the meeting over to Mr. Rocklaff.

Speaker 2

So thank you everybody for your time today. Thank you for your questions. Look forward to seeing those of you at ASCO who are attending and look forward to updating you as we move towards approval and launch of Avamisil later on this year. Thanks a lot. Take care.

Operator

Thank you. The conference has now ended. Please disconnect your lines at this time and we thank you for your participation.

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Adaptimmune Therapeutics Q1 2024
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