Juli Miller - Media Relations James Noble - Chief Executive Officer Adrian Rawcliffe - Chief Financial Officer Rafael Amado - Chief Medical Officer Gwen Binder-Scholl - Chief Technology Officer Helen Tayton-Martin - Chief Business Officer Bill Bertrand - Chief Operating Officer.

Eric Schmidt - Cowen and Company Jim Birchenough - Wells Fargo Tony Butler - Guggenheim Securities Peter Lawson - SunTrust Robinson Humphrey Jonathan Chang - Leerink Partners Reni Benjamin - Raymond James Jenny Leeds - Bank of America Kripa Devarakonda - Citi.

Good day. And welcome to the Adaptimmune First Quarter 2017 Financial Conference Call and Business Update. Today's conference is being recorded. At this time, I would like to turn the conference over to Juli Miller. Please go ahead..

Good morning. And welcome to Adaptimmune's conference call to discuss our first quarter 2017 financial results and other business updates. As a reminder, today's conference call will contain forward-looking statements.

These statements relate to future events or the Company's financial performance and the listener is cautioned not to rely solely on these forward-looking statements.

Such statements are subject to certain risks and uncertainties, which could cause actual results and events to differ materially from any future results expressed and/or implied by such statements, especially those inherent in the process of discovering and developing our therapeutic candidates and those set out in our filings with the SEC.

With me on the prepared portion of this call are James Noble, our Chief Executive Officer and Adrian Rawcliffe, our Chief Financial Officer; Rafael Amado, our Chief Medical Officer; Gwen Binder-Scholl, our Chief Technology Officer; Helen Tayton-Martin, our Chief Business Officer, and Bill Bertrand our Chief Operating Officer will be available for Q&A after the prepared portion.

This call is expected to last approximately 30 minutes. With that, I'll turn the call over to James Noble.

James?.

Thanks Juli and good morning everyone. And thank for joining us. Today's call will be brief. Overall, we will update you on our current financial position, as well as our clinical and manufacturing progress. We will provide a little more color on these topics during the call and allow some time for answering any questions you may have.

On the financial front, I am pleased that we recently completed two offerings, a public offering in March as well as a registered direct offering to Matrix Capital Management in April, which raised combined total net proceeds of $103.2 million.

With these offerings, Apadtimmune is funded through to late 2019, which provides us with a clear runway to deliver clinical data from our multiple SPEAR T-cell therapies, including our wholly owned asset, as well as our invasive program that is under option to GSK. Adrian will provide more detail regarding our financial status later in the call.

We remain on track with our clinical programs and we are positioned for important data delivery in 2017 and 2018. We continue to benefit from improved momentum in screening and recruitment across our trials, which we described during our last call.

We had identified and antigen positive patients in both triple tumor and the non-small cell lung cancer studies with MAGE-A10. We are screening patients for the multi-tumor with MAGE-A4 under our screening protocol and expect to initiate this study very shortly.

And as you would have seen from this morning's announcement, I'm pleased to report that our AFP study in hepatocellular carcinoma is now open for enrollment. We anticipate initial data from these three wholly owned assets in up to eight tumor indications, as well as additional data from NY-ESO this year and next.

Of note, with respect to our ongoing NY-ESO synovial sarcoma study, we will provide an update on data from all four cohorts as an oral presentation scheduled for June 5th at the upcoming Annual ASCO Meeting. In addition, we will present posters on the trial design for our MRCLS study and our two ongoing MAGE-A10 trials.

We will continue to keep you updated as relevant data become available across all of our studies. Highlights from the first quarter include. First, the FDA accepted our IND application for SPEAR T-cell therapy targeting MAGE-A4. And as I mentioned earlier, the multi-tumor study with this wholly owned asset is planned to initiate very shortly.

Secondly, both FDA and EMA have provided comment on the design of our planned registration study of NY-ESO in synovial sarcoma.

Furthermore, the FDA and the EMA has stated that the current single arm study, as designed, could provide sufficient evidence to support a regulated submission and we remain on track to start registration trail around the end of this year.

Thirdly, GSK nominated PRAME as its second target, reflecting its continued commitment to developing noble immunotherapies. Fourth, we received notification from the FDA that we have permission to proceed with our new cell manufacturing process to NY-ESO in phase I/II studies. All of our INDs have been updated with this new cell manufacturing process.

This process has been implemented for our ongoing NY-ESO and MAGE-A10 studies and would also be used to our AFP and MAGE-A4 studies. And finally, we announced that Dr. Helen Tayton-Martin assumed her new role as Chief Business Officer and Bill Bertrand joined Adaptimmune as Chief Operating Officer.

So overall, we expect 2017 and 2018 to be data and milestone rich periods for us, and we have the funding to carry us through to late 2019. And with that, I'll turn the call over to Adrian for his review of our first quarter and recent financial results.

Adrian?.

Thanks, James. As was mentioned at the start of the call, we completed offerings in March and April that in combination raise net proceeds of $103.2 million.

We are, therefore, in a strong financial position with operations funded through to late 2019 and this will give us adequate limelight to deliver data from multiple SPEAR T-cell therapies, including our wholly owned assets.

To provide a little more detail, as of March 31, 2017 and as shown in this morning's press release, Adaptimmune had $170.6 million of cash and cash-equivalents and $33.1 million of short-term deposits, representing a total liquidity position, which I’ll remind you as our non-GAAP measure of $203.7 million.

This $203.7 million is inclusive of the net proceeds from the March 2017 public offering of $61.4 million but does not include the net proceeds from the more recent April 2017 registered direct offering to Matrix, which raised net proceeds of $41.8 million.

Thus, following the registered direct offering to Matrix, Adaptimmune had cash and cash equivalents of $211.6 million, short term deposits of $33.1 million and a total liquidity position, therefore, of approximately $245 million.

And it is this updated position, inclusive of the April registered direct offering, which enables us to be confident that we're funded through to late 2019. Our total liquidity position increased by $22 million in the quarter, excluding the $61 million we raised in the March follow-on offering.

Our change in total liquidity position or cash burn was $39 million. And this compared to $6 million in the fourth quarter of 2016. And this disparity if you impart to the payments received from GSK in the fourth quarter of last year of $17 million compared to $1 million received during the first quarter of this year.

And as discussed previously, this represents normal lumpiness in the milestones associated with our collaboration. Also included in the quarter one cash burn is capital expenditure as we built out our Philadelphia navy yard site and our new building in the UK.

Looking at the remainder of 2017, we will continue to prioritize our expenditure to focus our efforts on delivering data from our wholly owned assets, as well as initiation of the registration study of our NY-ESO SPEAR T-cell in synovial sarcoma and the initiation of manufacturing from our Philadelphia Navy Yard facility.

With that, I'll turn the call back to James for some closing comments, James..

Thanks, Adrian. To sum up, the timelines that we set forth on the last call remain intact and we continue to be in a period of significant clinical momentum with funding that will carry us through to late 2019.

We expect to deliver initial data from our wholly owned assets in 2017 and 2018, as well as additional data from the NY-ESO program under option to GSK. With that, I'd like to open the call up for questions.

Operator?.

Thank you [Operator Instructions]. We will now take the first question from Eric Schmidt from Cowen and Company. Please go ahead..

Just a quick one or two, around the ASCO data set for NY-ESO 1 and cohort 4; I think you expanded that cohort up to 15 patients.

Can you tell us about how many patients we might see at the meeting and specifically whether any of the patients with the 1.5 version cell manufacturing will be included in the presentation?.

I'll let Rafael answer the question direct..

Yes, so at ASCO, we will provide updated data on cohort 1 and then existing data on cohorts 2 to 4. We would not have had sufficiently matured data on any patients that we process 1.5 those are right now ongoing and the data cut off was at the end of April.

So there would be all patients accrued and with response assessment after that time point that we will present, which is -- all the patients that were enrolled in cohort 3 which we have said previously was close because of lack of sufficient activity.

And then all the patients enrolled to that point in cohorts 2 to 4, which has not completed yet, neither of them but there is sufficient data, I think, given to provider color on what we're seeing both in low expression in as well as in modified Fludarabine cyclophosphamide regimen..

I guess in terms of cohort 4 and 1.5 manufacturing process, what kind of follow up do you think you need to get on the few patients with that process in order to be confident and moving forward with the pivotal?.

It’s a good question. We want to treat at least half a dozen patients or so. As you know, we have performed very extensive characterization of that process and submit it to FDA, which was the basis of their approval for us to proceed.

But we want to see some evidence of clinical activity and importantly persistence both keep persistence as well as some durability of persistence. We're confident that we're going to get that information this year given our base of accrual and patients that have been identifies for process 1.5, are all nearly identified already.

So we’re manufacturing now and we would have treated sufficient patients, and I think have enough follow-on by the time we have to initiate the trials, haven’t been able to make a choice..

Thank you. We will now take the next question from Jim Birchenough from Wells Fargo. Please go ahead..

It’s Mick in for Jim this morning. I am taking questions, I know that I think in your prepared comments you said the single arm phase III trials for synovial sarcoma would be acceptable by FDA. Did you also say that will be acceptable for European regulators, or what is the hurdle in Europe? And I have a follow-up..

Yes, it's both. And also be ready to quick, the FDA and EMA has stated that the current single study as designed could provide sufficient evidence for regulated submission. And if that, we think, obviously trying to coordinate the two for some month.

Rafael, do you want to add anything?.

Nothing much more to add, the discussions with EMA have been ongoing in the context of the priority medicine designation. Regulatory authorities, obviously, prefer around the mice trials but they also acknowledge by having granted both priority medicines that those trials would take longer, given that this is an orphan indication.

And they have agreed that the current design could support an application and that has involved quite a regular review by both agencies on the protocol and this provided a lot of helpful comments that we’ve incorporate in the design..

So were there any discussions of the historical control or some kind of matched control, just sort of anything new of the registered randomized trial design?.

Yes, that’s an excellent point. There was discussion about randomization. But as I said, the decision in the end was that this initial trial would be I think a long trial. There may be other trials following this one that we’ll have an opportunity to discuss in the future.

And obviously any decision was being done in partnership with GSK who is our partner on this option program. We will, however, explore historical data based on large data bases from centers that have been treated synovial sarcoma to be able to provide some context to our results..

And then on myxoid/round cell liposarcoma.

Have you actually been able to enroll some patients from that trial yet?.

The trial is ongoing and it's enrolling..

And then actually the last one from me, on the Bellicum collaboration, is there any update on how that's going and whether you’re still on track to be able to make a decision by year-end..

I'll ask Helen to answer that because she is in-charge of the collaboration..

And yes the Bellicum collaboration is on track. We had a very good kick off discussion at the beginning of the year and things are beginning to track according to the match up proof of concept plan. So yes we are on track with that for reveal results by the end of the year..

Thank you. We will now take the next question from Tony Butler from Guggenheim Securities. Please go ahead..

Two questions, if I may. Rafael, first cohort 3 you alluded to had lack of activity.

Was that the assumption, because I believe treatment of those patients was with cyclophosphamide only? Or does that imply that in future trials not only with NY-ESO but with MAGE or AFP, there will be the use of both cyclophosphamide plus fludarabine? And the second question, James, remind us now that GSK is nominated PRAME.

What are the next steps that Adaptimmune actually takes moving that construct into the clinic? Thank you very much..

I'll take the second one first, and I'll ask Helen to talk about that because she is in charge of the GSK deal..

So with the nomination of PRAME, the next step is to move candidate TCLs through preclinical testing and that work is already underway.

At which point, when we have an IND package ready for that program which potentially is by the end of -- by or around the end of this year, the first quarter's next year, then GSK takes us toward this option that or not.

So at this point, it's nominated PRAME just take it on itself, it would then exercise an options based on the IND package based on preclinical data..

And just to add, Tony, just to be clear and for anybody else on the call, anything nominated by GSK apart from NY-ESO, they have to do the clinical work.

So we actually hand it over at IND package as a completely different type of program for GSK that they actually take it over at IND if they determine, as Helen said, that the IND package is sufficient. And as I shared that’s around the end of the year..

That's helpful, James. Thank you..

And Rafael I’ll ask, to answer this first question..

Tony, your question in cohort 3, which use only cyclophosphamide for conditioning, use the same dose of cyclophosphamide as cohort 1, which is relatively high dose. That cohort made pre-certified criteria for futility, so we closed it earlier than the accrual goal which was 10 patients.

It was not completely inactive so we have seen activity in that cohort. But it was inferior to the activity that we have seen in cohort 1, and given that we already have a benchmark that's quite important for these patients. We couldn't justify accruing more subjects in that cohort.

And you're correct on your assumption that, going forward, our programs are going to include Fludarabine in the condition criteria..

Thank you. We will now take the next question from Peter Lawson from SunTrust Robinson Humphrey. Please go ahead..

James, so it's a really nice set of data coming in synovial NY-ESO, AFP, PRAME, et cetera.

How should we think about the timing of this data and order this data beyond ASCO?.

I mean the answer is it's going to depend entirely for -- you're going to get a complete update it's actually on synovial sarcoma at ASCO, as you say, so that's all four cohorts; the post that, it's going to be when we have enough patients to give a reasonable assessment of what's going on.

So the first thing is that in each study, the first three patients get a modest dose, which is a safety cohort. And those have to be spaced out after the 21 day observation period between patients. So you won't recruit those. They're at least a month or whatever happens, those three, the first three patients.

Now obviously if something goes tragically wrong, we would have to announce that instantly, as you know, you’ve seen it across the sector that if things go wrong. But we're not going to announce whether we have actually dosed patient-by-patient and we're not going to announce data patient-by-patient.

So we're really looking for the second half of this year, first half of next year, to give the first data on MAGE-A4, MAGE-A10 and AFP. It really depends on the actual recruitment of patients..

And then the pivotal trial design for synovial sarcoma, that’s going to be a single arm.

How many patients will that enroll in a post the primary end point and then there may be other trials that are also needed for approval?.

Peter, the trial will be round about 50 patients plus. And in terms of whether there will be other trials; obviously, our current pilot trial would be an important part of the application. And then we will supplement the application with safety from the ongoing studies in the NY-ESO program outside of synovial sarcoma.

But we don't expect to have to need additional pivotal trials for this submission..

So there's, kind of 50 patients for this kind of -- so there's almost like pilot pivotal trial.

Is that how we should think about it?.

There's been in oncology approvals based on response with trials of this size, so this isn't completely unusual. And as I said before, there will be quite a good database already in synovial sarcoma coming from this pilot that we are already executing in cohorts 1 to 4..

And then the primary endpoints, I missed that..

So the primary endpoint will be response given that existing going trial and of course we will look at all the additional endpoints, including durability and other types of events endpoint and it's always a benefit, really; so obviously, the safety profile of the product..

So we should be thinking as that endpoint?.

Correct..

Thank you. We will now take the next question from Michael Schmidt from Leerink Partners. Please go ahead..

It's Jonathan Chang stepping in for Michael. Thanks for taking my question, just one from me. In light of the more recent safety concerns regarding CAR-T therapies, can you remind us the reasons for confidence in the safety profile TCRs? And what you’ve seen to-date in terms of safety? Thanks..

I’ll ask Rafael to comment on that..

So Jonathan, I don’t know much more or anything more than what’s historically available on the recent events with CAR 19, both with [indiscernible] 16 and CAR product that was basically announced. And therefore, it's difficult for me to speculate what may be behind those sets.

Clearly, one of the common features is the presence of cerebral edema and they appear to be quite prominent and very ready early on. We have seen none of that in our programs, and obviously, we don’t do work with CARs and we don’t have CD19 as the target.

And all we can say is that the profile, the safety profile of our product; has never included any neurological events, any events of encephalopathy features, which are relatively common with those programs; and certainly any deaths related to neurological events.

As James said, we’re presenting the data in our oral presentation at ASCO and we will summarize the most recent safety data in the synovial sarcoma program, which is very representative of the safety data as a whole of the NY-ESO program.

And we’ll be able to provide more color during that presentation around the safety profile that the neurological events are, especially absence in the NY-ESO program..

Yes, just to emphasize that. We have not seen any of those neuro tox things that have been in the CAR T-cells, it is really, really a big differentiating factor. And you're not going to any nasty surprises at ASCO on that school. The ASCO will just give the data fully but it won't give you any nasty surprises on neuro tox..

Thank you. We will now take the next question from Reni Benjamin from Raymond James. Please go ahead..

This is [indiscernible] for Reni. Thank you for taking my questions. I just have one here, so if we -- given that we're going to see the first readouts from some of your T-cell programs. So I was wondering if we compare NY-ESO TCR with MAGE-A10, A4, in terms of the expression level, pre-clinical readouts or any other metrics that you may have.

I was wondering, have you seen anything that you think these two TCRs may potentially be better than NY-ESO in terms of efficacy? Thank you..

Yes, that's an interesting question. We do of course have quite a lot of preclinical data. And actually, since it's all in the public domain, we can refer you to slide showing the safety profile against the 72 tissues. With MAGE-A10 and MAGE-A4, the special profile in normal tissue is similar to NY-ESO in terms of not being expressed in normal tissue.

The profile expression in cancer is point different and again in our presentation we've got the data base, levels of expression, as a percentage of cancer patients expression relevant antigens from which you will see that MAGE-A10 is in relatively modest sort of 28% to 18% of half of dozen cancers whereas MAGE-A4, and that's why we are in seven cancers right up from with MAGE-A4, is up to 50% to 60%, and across the much broader set of cancers.

We can actually just send you those because those are in the public domain, so that's easy after the meeting. So in terms of killing function, both MAGE-A10 and MAGE-A4 pre clinically are better killers than NY-ESO whether that remotely translates into clinic. We’ll obviously tell you at the time, but they are very good killing agents.

They have both been optimized for affinity, so you won't go high or low, they are at the optimum level. And optimum level includes killing assays as well as -- and are those potency assays, as well as obviously safety assays in terms of cost of activity. So they have been absolutely optimized, so we just see what happens in [indiscernible]..

Thank you [Operator Instructions]. We will now take the next question from Ying Huang from Bank of America. Please go ahead..

This is Jenny Leeds on for Yang. Thank you so much for taking our question. I just had one about AFP and then the trial that you started. If you could speak a little bit about ASP expressions that you’re kind of the threshold I guess for inclusion criteria in this trial.

And then what that within the HCC market, what percentage that would be, and then also when we’re thinking about the different HLAs that could be enrolled in that trial. And what presented to these patients would have kind of both the tumor antigen as well as the necessary HLA for treatment? Thank you..

So I'll start with the HLA. The HLA 2, which is the same as the NY-ESO, MAGE-A4 and MAGE-A10 programs and is consistently somewhere between 40% and 50% of the U.S. population, and I'll let Rafael give you answers to the other questions..

Yes, in terms of the expression we’re using a high cut off expression of onco-fecal protein. We don’t know exactly how that's going to pan out in terms of how many -- what the percentage, but we’re being after this study suggest that maybe up to a third of patients, and we just see as we start screening more and more patients.

This is a phase I study so there are a lot of other inclusion criteria beyond expression. And of course one of them is lack of expression about the fecal protein outside of the tumor. And so it's difficult to extrapolate the patients that will come into the study towards what will be in the real world.

But those are the expression numbers and HLA aid to positivity that we know thus far..

Thank you. We will now take the next question from Kripa Devarakonda from Citi. Please go ahead..

I was wondering if you can talk about whether there's been any change in rate of enrollment for ovarian cancer studies with NY-ESO, and also a little bit more detail on how many patients you expect to enroll? And when we might see data from the trial? Thank you..

So in terms of NY-ESO trial, the first cohort of six patients without fludarabine it's close. So we're just starting a new cohort, which could involve up to 10 patients, depending on the availability of those patients. And we haven't given any data out on that yet.

It is very slow to recruit, which gives you the impression that the expression levels in ovarian cancer are much lower than actually in the literature. So I think that's one of the areas we think that the published percentages of antigen expression are not right in the real world.

Rafael, do you want to add anything to that?.

Nothing further to say other than it's accruing, but it's slow. And so we are putting patients on the fludarabine cohort now, and we will update data set once we have sufficient data with the use of fludarabine..

Thank you. We will now take the next question from Peter Lawson from SunTrust Robinson Humphrey. Please go ahead..

James, just thinking about data, so do you think that there's going to be anything at ASMO, and then the MAGE-A10 and A4.

Which of those indications are rolling as fastest as some -- any color you can give around A10, A4? And do you find it hard enrolling against the IO therapies that are out there?.

So in terms of, just to be clear, MAGE-A10 is enrolling right now and MAGE-A4 isn't, because the vector hasn't been released yet, although that’s imminent.

In terms of what we expect then you'll get as I mentioned you can't really get more than one patient a month for the first three months, so they would enroll at the same speed once you find patients, if you like for first three.

After that, I would expect MAGE-A4 to enroll much more quickly than MAGE-A4 because of the expression, the percentages and because it’s in seven different tumors. And also because we're starting with a much larger database of people we already know, are HLA II positive from the screening protocols and the MAGE-A10 study.

So I think that my own personal view is that we will actually discuss some of the numbers of people we discovered that are MAGE-A10 positive at ASCO in the bundle of posters. But we're not going to talk about whether or not we’ve dosed anybody. So I think they’ll start at the same speed and then MAGE-A4 will get much quicker.

I have to say, Peter, in our experience the moment you get a signal in any particular indication that's when recruitment goes up, because you suddenly have great enthusiasm from all the medical school our patients are on. I'll ask Rafael to say whether other trials are displacing patients to make it harder for us..

Well, I think, first I would say opening MAGE-A4 would be helpful for MAGE-A10 as well, because there is some overlap between the two markers. And so because of the contingency in the trial patients have to be picked out of period of time depending on what cohort they’re in and what GLPs have been observed.

Some of these patients may be positive, but it has to wait to actually get the cells even if we prepare the cells ahead of time. So having MAGE-A4 and assuming overlap then allows us to manage accrual to one trial versus the other better.

And also because we did screen a lot of patients already for HLA, we have a large number of patients that we already know are actually A2 positive that we can go straight to A4 screening, and that’s already occurring because the screening is occurring under a screening protocol, which is separate from MAGE-A4 protocol.

And then lastly MAGE-A4 is more common than A10, so for all these reasons, we are optimistic about how MAGE-A4 will go. We're also opening sites, including community sites, and so we are -- and sites in Canada, as well. So I think the set up is quite good.

In terms of tumor types that may be more common, I mean we're seeing positivity across all the tumors that are eligible in MAGE-A10, and we expect to see this training A4. And whether there’s competition for other studies, of course, there is competition in the centers where we are there, there are lots of trials.

But we worked pretty closely with investigators to time when patients go into our trial, and monitor them very quickly. So we don’t expect this to be a barrier when it comes time to the patient to get in. And so just the firm line is we’ll remain optimistic and I think our MAGE-A4’ portfolio will be a positive event for the entire set of programs..

Thank you. There are no further questions in the queue, at this time..

Thanks very much, everybody. I think we feel very upbeat about where we are, and we look forward to post the data over the next -- rest of 2017 and 2018. So see you all at ASCO. Thanks..

That will conclude today's conference call. Thank you for your participation, ladies and gentleman. You may now disconnect..