Will Roberts - VP, IR James Noble - CEO Rafael Amado - Chief Medical Officer Adrian Rawcliffe - CFO Gwen Binder-Scholl - CTO Helen Tayton-Martin - COO.

Michael Schmidt - Leerink Partners Tony Butler - Guggenheim Securities Reni Benjamin - Raymond James.

Good day and welcome to the Quarter Three 2016 Adaptimmune Earnings Conference Call and Business Update. Today's conference is being recorded. At this time, I would like to turn the conference over to Mr. Will Roberts. Please go ahead, sir..

Thank you, Anne. Good morning and welcome to Adaptimmune's conference call to discuss our third quarter 2016 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 risk and uncertainties which could cause actual results and events to differ materially from any future results expressed in 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 call this morning and participating in the prepared section of the call are James Noble, our Chief Executive Officer; and Adrian Rawcliffe, our Chief Financial Officer, Rafael Amado, our Chief Medical Officer; and Gwen Binder-Scholl, our Chief Technology Officer, Helen Tayton-Martin, our Chief Operating Officer, will be here available for Q&A after the prepared portion.

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

Thanks, Will. Good morning, everyone. And thank you for joining us. We plan to cover a number of topics on the call today, including updates in our recent business enhancements, progress across our clinical and preclinical programs and our financial results for the quarter.

Since our last update, we have made excellent progress and now in a period of strong momentum across the business. First, we were very pleased to announce yesterday that the FDA has removed the partial clinical hold on our plan filed for the NY-ESO SPEAR T cell and myxoid/round-cell liposarcoma or MRCLS.

We plan to initiate a pilot MRCLS trial and start screening patients around the year-end as previously guided I want to reiterate that this was a partial hold that only affected our MRCLS registration study protocol.

We have made good progress in many other studies in the interim and this partial hold was not due to concerns regarding safety in this trial had not yet started, not were there any concerns regarding the planned preconditioning regimen with cyclophosphamide and fludarabine.

The CMC request underpinning the partial hold stemmed primarily from the fact that we are in the process of evolving our manufacturing from an academically derived process, which we call 1.03 to a commercial ready process, which we call 1.5. The original MRCLS protocol is going to be the first to utilize product from this new process 1.5.

In short, the FDA are in the context to a registration trial for more data regarding our switch from 1.0 to 1.5, including comparability.

Because we did not want to delay initiation of this in our MRCLS patients, we changed this to a pilot study using our current management process 1.0 to supply, as we worked to finalize our commercial ready process to supply all future registration studies.

The original MRCLS protocol was designed to be a registration study and included a futility analysis to be conducted with the first 13 patients. A futility was not met and enrollment would proceed to a maximum of 35 patients. We have now decoupled the originally proposed registration study into two separate studies so that we can start right away.

We will commence with a pilot study in up to 15 patients to assess preliminary safety and efficacy, which is not unlike the futility phase of the original protocol. Data from this pilot study will then inform a plan registration study. As I confirmed earlier, we expect to start screening patients for the pilot study shortly.

Given the significance of MRCLS with patients impacted by this rare cancer. Our goal is to move this program toward a registration study as expeditiously as possible.

The timing of initiation of the plan MRCLS registration study will depend on the pilot and the decoupling of pilot with registration study will ensure the comparability days are available to support the planned registration study.

With respect to business development over the last quarter, as leaders in the field of T-cell cancer immunotherapy, we have sort strategic partnerships to assess all potential avenues to further advance our technology. As such, we have formed two partnerships in recent weeks. First, we entered into a multi-year line for the University of Texas M.D.

Anderson Cancer Center to advance the development of our cancer immunotherapies. And secondly, we announced the clinical trial collaboration to assess our NY-ESO SPEAR T cell therapy alone and in combination with KEYTRUDA Merck’s PD-1 inhibitor in patients with multiple myeloma. This study is planned for initiation in the first half of 2017.

Under this agreement Merck will provide drug for the study free of charge, and Adaptimmune will conduct the file with the company's coordinating activities through a joint development committee and depending on the outcome, we would have the opportunity to expand this relationship further into additional stages of development.

You may have noticed there have been several changes to our board and I'd say over the past six months, including transitioning to a new chairman at the end of 2016. These changes are reflective of the continued evolution of Adaptimmune as a public company with three new independent directors joining the board in recent month.

At the same time, we have announced the departure of two board members who also served on the board of Immunocore, reflecting our growing independence for logistic [ph] company.

This evolution towards pools independent is further underlined by the mutual decision to end target identification collaboration between the two companies because we have now established our own capability to identify new Adaptimmune targets.

We have had a long and productive collaboration with of Immunocore with a significant joint target safe base to which we will have full access moving forward. We will continue for us to prosecute this IP with Immunocore. Moving on now to our ongoing clinical work.

I would like to briefly cover the importance of the preconditioning regimen across all trial. We have convincing data showing fludarabine is required as part of our preconditioning regimen for optimal cell expansion activity.

And I want to reassure you that we have not seen the type or severity of neurological in the presence of fludarabine that have been reported in some studies of CAR T.

Thus far, this is consistent with a generally better tolerability profile overall of our NY-ESO SPEAR T cell therapy, as compared with CD19 CAR T, including a much lower incidence of serious cytokine-release syndrome.

As such, all current and future protocol for our trial will include fludarabine in combination with cyclophosphamide for preconditioning generally at similar doses of those used by peers in the CAR T space. On to other preclinical and clinical update.

First and foremost our wholly owned pipeline is becoming an increasingly visible element of our business. We recently initiated MD Anderson as the first site in a triple tumor study of MAGE-A 10 spear T-cell therapy in patients with urothelial, melanoma or head and neck cancers.

Our MAGE A 10 study in non-small cell lung cancer is also going for recruitment. We expect to see data from both of these studies in 2017. Further, we continue to expect to initiate enrollment in the first study of AFP with a T-cell therapy in the first half of 2017 and the R&D for our MAGE A 4 spear T cell submission remains on track for early 2017.

Secondly, we announced at ESMO that we had initiated dosing with our NY-ESO SPEAR T cell therapy in cohort four synovial sarcoma program, utilizing the modified fludarabine and cyclophosphamide regimen.

Encouragingly we continue to experience strong interest in the study and have already enrolled a majority of the patients for this cohort and we expect to begin registration studies in this indication in the second half of 2017.

Thirdly, we announced the amended protocol for evaluating NY-ESO in ovarian cancer patients is now open for enrollment with the same modified fludarabine and cyclophosphamide preconditioning regimen, as synovial sarcoma cohort 4. Fourthly, enrollment is also now underway in our study of our by NY-ESO SPEAR T cell in non-small cell lung cancer.

And finally, there will be an update on the NY-ESO sarcoma study at CTOS tomorrow, included or updated data showing an encouraging increase in median survival in cohort 1. Moving on to manufacturing, ensuring a long-term supply or our spear T-cell therapies remains a priority and we have continued to make good progress in that regard.

First, I can confirm that we anticipate the opening of our owned manufacturing facility in the Philadelphia Navy Yard technology center around the middle of 2017. When all modules are buildout, this facility will have the potential to produce therapies to up to 1200 patients per year with an initial capacity of around 3 to 400 doses.

Secondly, we announced a new five-year strategic manufacturing supply agreement with PCT, and we have also initiated a relationship with the European contract manufacturer of master [ph] cell. Once our own manufacturing facility is online, these partnerships will augment our entitlement manufacturing capabilities.

Lastly, we have made good progress in moving from the academically derived manufacturing process 1.02 to our commercial ready process 1.5 and as I discussed earlier, we have an agreed-upon plan with the FDA to move forward with this process to future registration studies. And so good progress of momentum across the organization.

And with that, I'll turn the call over to Adrian for his review of our third quarter financial results.

Adrian?.

Thanks, James. And good morning, everybody. As you saw from this morning release, I am pleased to say that we closed our 2016 third quarter with nearly a $188 million in terms of liquidity. This is a non-got measure comprising cash, cash equivalents and short-term investment.

So we remained well-capitalized and our guidance has not changed and that we believe that currently forecast spend levels this cash should last us into mid-2018. Let's touch briefly on the financial highlights for third quarter of 2016.

Our revenue comprised primarily of payments under the GSK agreement was $2.4 million for the third quarter 2016 compared with $4.9 million in the same period in 2015.

As discussed previously, our revenue will continue to variable based on the achievement of recognition of milestones which you will remember are designed to offset the cost associated with the NY-ESO program and with other elements of the collaboration.

Regarding our R&D expenses, with progress in our pipeline come the need to controlled investment into ongoing and planned clinical studies, into preclinical activities to identify new targets and deliver new INDs from 2017 onwards, and into the talented people performing the work.

As such our R&D expenses were $15.6 million for the third quarter 2016 compared to $8.9 million for the same period in 2015.

The increase in general, it demonstrated expenses period-over-period related almost entirely to increased personnel costs as we invested appropriately to ensure we are starting to execute our business plan and deliver our results, these were $5.4 million for the third quarter of 2016 compared to $4.4 million for the comparable 2015 quarter.

All in, we reported an operating loss for the third quarter of $18.6 million, which are salary expenses and taxes get us to a net loss of $18.5 million.

On a per ordinary share basis this translates to a loss of $0.04 per ordinary share for the third quarter 2016 and there are six ordinary shares represented by HIDS [ph], we show a net loss of $0.26 per ADS.

The construction of our new facilities in Philadelphia and OXFORD in the UK was making good progress and we remain on track to occupy both buildings in 2017. The land work is complete to the Schenkel construction of both buildings and we announced switching out the facility.

Q3, we incurred capital expenditure of $2.8 million, which largely relates to these facilities and is an increase of $1.6 million compared to Q2, 2016.

Finally, we are reiterating our previous guidance, excluding the effect of any potential new business development activities, we expect a decrease in total liquidity position for the full-year 2016 to be between $80 million and $100 million.

We therefore expect our total liquidity position at December 31, 2016 to be at least $150 million and we believe we have funding today to take us into mid-2018. With that, I want to turn the call back over to James, for his closing comments. James..

Thanks, Adrian. I believe that the work ongoing at Adaptimmune has the potential to improve patient outcomes across a variety of diseases.

This potential derives from the caliber of our scientist who are conduct industry-leading science at the forefront of the immune oncology revolution and the outstanding development professionals who are driving forward the manufacturing and clinical aspects of our programs and I want to thank them for their work and dedication.

Well, doing that without risk, this is a period of exciting progress throughout the company, thanks to our active engagement in the important new partnerships and to momentum across our clinical pipeline and manufacturing organization.

We will continue to develop our preclinical asset towards filing new INDs each year from 2017 onward and expect to have clinical studies underway with at least four spear T-cell therapies in up to 10 centers with data from many of these studies in 2017. And we expect to be the first TCR Company to enter registration studies for receptor therapy.

We are accelerating towards all of our corporate goals, generating important new data in multiple tumor types, building clinical expertise by initiating, conducting clinical studies with new constructs, aggressively bringing new INDs towards the clinic, developing TCR targeting our broad pipeline of solid tumor targets and exploring the possibility of enhancing the debt and durability of our affinity enhanced SPEAR T-cell therapies, utilizing combination and/or second and third-generation strategies.

The remainder of 2016 and 2017 is an important time for us and we thank you for your continued support. With that, I'd like to open the call up for questions.

Operator?.

Thank you so much, sir. [Operator Instructions] Our first comes from Michael Schmidt from Leerink Partners. Please go ahead. Your line is open..

Good morning and thank for taking my questions.

I had one on your manufacturing process in particular you mentioned the transition to the version 1.5 process and I was wondering if you could talk of some of those differences and you know, in your discussions with the FDA requesting you'd show comparability whether that is limited to C&C features or includes also clinical comparability? Thanks..

So I'll let Gwen Binder-Scholl to the loans manufacturing answer there..

Yes. Hi, Michael. The Takeda [ph] centers which won a few processes and it has to do with three areas of the manufacturing. The first is we've incorporated free start in the increases which provides us with a lot of flexibility of manufacturing scheduling.

The second is we simplified the upstream verification of process and so now it’s a single step enrichment of T-cells, so we removed some complicated steps which enhances our ability and reproduce ability of the process.

And the final as we simplified the T-cell media and reduced serum requirements as well, so that has implications both in reducing clean run time and also reducing supply chain risk.

And then your second question was about comparability and so all of our comparability studies are in vitro [ph] studies and we are not doing any clinical - we have not been required to do any clinical comparability, so it’s also center of the call..

Great. Thank you. And then my other question was around the safety profile of your on engineered TCR base, T-cells in general and James you mentioned that the potentially better for ability compared to CAR T in terms of TRS and neuro talk, and I was wondering what the rationale of the theory is behind that tolerability? Thank you..

I'll ask Rafael Amado, our CMO to address those questions. First on the actual talk we've seen and then maybe we can discuss some of the reasons behind them..

Yes, Michael. So in terms of toxicity and we do see the majority of patients having adverse event which in by in large relate to their conditioning and so those are all as you might expect events that have to do with mild depression and complicated chemotherapy that are transient and early manageable.

When we talk about the specific events that you may see, cell therapy, CRS will continue to see lower incidents than that has been described with CAR19 product and it’s in their high 20%, and we found 20 plus patient we thought to take a single great for event, so most of them are our great city and we've learned - we another customer and a lot about the management of CRS and early institution Ontario [ph] fixed therapy.

So it’s becoming something that I think the field is managing well and but there's no question now that the incidents of severity that we see is lower than what seeing at least with a CAR19.

I think there is a lot of speculation as to what that can be due to including two more bulk, ready access to the target cell, et cetera which is - it’s much higher with CAR19.

In terms of neuro 12 [ph] we had sincerely had seen nothing - again to what we've been seeing in the CAR19 space and you know the speculation for why that can happen I mean, I think you’ve heard some of this theories in the past and I don’t think anyone knows exactly why CAR19 in ALL and large cell lymphoma, not indications, [indiscernible] toxicity, that is very - I think it’s a very well defined syndrome that we have yet to see in this space and whether it is some target expressing the brain or the brain being a assentury [ph] for cancer cell to leukemia and some other speculations, I think that still needs to be determined.

I don’t think it’s due to fludarabine a chemotherapy agent per se because these are even in our high dose conditioning we haven’t seen that sort of complications. So I think that’s what we can say for now..

Great. Thank you very much..

We'll now take our next question from Peter Lawson from SunTrust Robinson Humphrey. Please go ahead. Your line is open..

Thank you. This is Shomitra [ph] for Peter Lawson.

Congratulations on the great progress and I might be asking this question a bit of ahead of the data, but trying to understand for the synovial sarcoma patients how many of them has nine month mark in your study, are those fixed responding patients because there is been response to the - to the abstract we saw saying at nine months one of the patent relapsed? And the second one is related to the manufacturing process, how much is it automated or closed system because of this NCI had the problem with the CART-D contamination related issue.

So we are trying to understand how much of is it semi-automated and that can be reverted? Thank you..

So on the first question its slight low, because we're actually - those patients are being released including the exact overall survival - the median survival data tomorrow at CTOS which is in Lisbon.

We have two sets of presentation, one is at SITC, which is obviously here in Washington DC in National Harbor, and the second is CTOS, so we're actually putting the data out there.

So in terms of the median survival and the data relating to progress on synovial, we are slightly hamstrung, all we can say is that we very encouraged by the increase in the median survival, since we last reported it being a year, which was six months ago.

And I will let Gwen Binder-Scholl talk about the extent of contamination and automation and manufacturing?.

Yes, hi.

I think for question, when we initially transferred our process from the University of Pennsylvania to our contract manufacturer, we did close almost all sets of the process and by the time we get to commercial manufacturer we'll be completely closed and we haven’t had contamination issues and so we transferred this process over to PCT and there are no concerns regarding contamination and manufacturing processes.

There hasn’t been an issue with us..

Thank you..

Our next question comes from Mark Thom [ph] from Cowen and Company. Please go ahead. Your line is now open..

Hey, guys. Thanks for taking my questions. First, maybe Rafael, you could give an update on the enrollment for MAGE-A 10 I know last time you mentioned there was a bit of a slowdown because of some the failure, to three new failures adenocarcinoma.

And then why the - and then maybe comment also on why the triple tumor trial also has a 3.3 3 plus 3 343 design and not just dose expansion?.

Yes. Thanks, Mark. So let me start with the last question, because we haven't finished dose-escalation alone, we have still the triple tumor as dose-escalation as well and we hope that we can leverage the information that we get between both trials and maybe we'd be able to move accordingly, a bit faster.

But they are designed as parallel trial and again, you will have to think sort of rules with regard to the waiting in between doses.

In terms of approval with the rest of the triple tumor that’s just getting going and then we understand and we're pretty excited about the collaboration and hope that that’s going to be a really helpful alliance for us to throughout the state and learn more about the therapy.

So there is lot of enthusiasm and we understand and obviously are adopting and we so we hope to see a lot of progress there. In line, its evidence of marker positive disease that remained low.

We thought again - we've made a lot of effort to touch screening - screening sarcoma patients and that’s being going well, actually there's a lot of awareness among investigators that market expression is higher in the sub-type of lung cancer and we're seeing a lot more screening lung cancer patents and coming to screening and we are actually finding patients that are positive and getting them through dose-escalation.

It’s still early days, but we're hopeful that this is going to pick up. We've also - as you can imagine made planning to increase the number of sites and we are in the midst of expanding to Europe to adapt to the expression levels that we're seeing..

Okay. Thank you.

And then back to NY-ESO, in synovial sarcoma, I think previously you mentioned trying to get a SPA in place for that pivotal trial, any updates on where those negotiations are and maybe where the kind of main points of agreement are to still need to be made?.

Yes. So we have agreed a principle to some key design features of the trial and for instance you know the fact that it will be a single arm study, what sort of with all level - we would consider clinically significant and so on.

Obviously designs and definitive agreements that I think we've had really good dialogue with FDA and the signal there are positive. We have decided to submit this. We are actively preparing for that and it will be submitted very shortly..

Okay. Thank you..

We will now take our next question from Tony Butler from Guggenheim Securities. Please go ahead sir. .

Thanks very much. James, in the original IND for myxoid/round cell liposarcoma, was the manufacturing at that time for the IND 1.0 and then in between the IND filing, and when you began to enroll patients that was when the 1.5 manufacturing process change occurred.

I’m just trying to understand the timing relative to the IND filing? And then secondly, on the same trial in the pilot, is – would there be a futility analysis following the pilot and is it – would it be true – regardless of the answer to that, would you just simply need, or do you feel you’ll need only 20 additional patients to achieve that same max number of around 35 for completion of the registration study? Thank you very much.

.

Thank you, Tony. So I’ll let Gwen to take questions on the manufacturing process and I’ll flack out and follow then up with a question on the futility analysis..

Yes. Hi, Tony. That’s a very good question actually regarding the manufacturing process and the IND. So the way our IND is structured is we have all of our NY-ESO studies under one IND. So when the next OS study was originally submitted, it was submitted under the IND that still had the process, original process within the IND.

And as we mentioned during the conference call, we’re in the process now of submitting the information regarding our updated process 1.5 to the FDA now. .

Thank you, Gwen. Now on the clinical design, Tony, or the trial design of this study. So it’s up to 15 patients. These are 15 patients and we obviously hope to be able to make a decision, we tend to say since depending on what levels of responses under ability we see.

In terms of what else would take to potentially getting enough data for registration in this indication, we have yet to make those decisions and come up with a plan because it’s really going to depend on what we see in the pilot trial.

It could very well be that we then require exactly what you said, another trial that enrolls another 20 patients or so. That’s certainly our hope but we’ll have to wait and see what we see from the pilot and what transpires from the FDA discussion. .

But we don’t expect the second feature that you have [ph]. .

No, that’s correct. .

Yes, because that then replaces the futility analysis because essentially because we haven't faced in MRCLS patient yet, so we obviously need to see the correct level of signal in the first up to 15 patients, registered patients there..

But still – yes, but still James it would be a quasi go/no-go decision, right, to continue that enrollment so by definition it’s kind of one in the same.

Is that fair?.

Yes, exactly right. .

And my other question then was around multiple myeloma.

At least some of the CAR-T companies had been using or considering using DCMA as a target and I’m curious your thoughts around that versus – and why you still – and how you think through the net number of multiple myeloma patients that may be more or less susceptible to NY-ESO TCR, which should be off with potent and has demonstrated potency at least previously in those types of patients? Thanks.

.

Yes, I mean, clearly in the CAR space, DCMA [ph] looks to be an infection target and although there is not a lot of data. The data that exist is promising. It’s I think early days to know how this technologies are going to play out. We’re excited about what we’re going to transplant study.

I think this new trial is designed to get an accurate measurement of what the NY-ESO TCR can do in the absence of mild ablations for transplant which is an important point for us, as well as what the combination can do to prevent resistance and lengthen durability of response.

And I think when it’s so early with that technology, it’s difficult to predict. I think a lot of it is going to boil down to how active each technology is and how safe they are, and of course there are other expression differences between the two markers and so on.

So I think it’s good that there is more than one option out there in myeloma for some therapy and it was just up to see how both evolves. .

I think the other thing, Tony, is that we are – and in fact the place to an SITC tomorrow but one of the second generation T-cell products that we’ve got under investigation.

We think it’s very important is generic sense ignoring the fact that this is multiple myeloma to find that the impact of either combination therapies or the second-generation program, so today we’re not – obviously we’re not talking about KEYTRUDA or multiple myeloma, but then tomorrow we’re talking about second generation and these are just the sort of first steps in working out exactly how to increase durability and that’s the response across the program.

So when it wouldn’t end up only being in multiple myeloma. What you need to do is you need to get a signal first and then to look at the effect of combinations or second generation. .

Thank you, James. Thank you, Rafael..

Our next question is from Haeng Kaung from Bank of America Merrill Lynch. Please go ahead. Your line is now open..

Hi, good morning. Thanks for taking my questions. First of all, can you tell us a little bit about the expected time line on reporting the cohort for of synovial sarcoma study.

And then secondly, one follow up again on the announced small cell lung cancer enrollment, can you tell us how many more new sites have been opened and the slow enrollment is that a result of lack of NY-ESO or MAGE-A10 expression, or it’s because of the competition from other immune check point trials in the centers? And the lastly, in terms of your 1.5 or 2.9 manufacturing, can you talk about whether there is any reduction in manufacturing time? Thank you..

So I'll let Gwen answer the manufacturing question first and then we'll come back on the other two points..

Sure. Thanks, Haeng for your question.

So we have not change the manufacturing time, right now we don’t feel that the duration of manufacturing is any impediment for us to get the product to the patient in a reasonable period of time which right now is four weeks and we also feel that timeframe of expansion of the T-cells enables us to activate and extent the T-cell in order to achieve our targeted dose and that extension allow us to begin the manufacturing with smaller numbers of T-cells in the and also the reduces the cost of certain creation as well.

And so the real changes on to the manufacturing and I think we could probably take four at our current process 1.0 commercially if we need to, the changes that we're implementing are really mean to reduce the cost of goods and actually increase our manufacturing flexibility and reproduce ability, that’s really the course..

Rafael?.

Yes, and so in terms of the lung cancer studies, actually screening is pretty great and it’s proceeding nicely. So I don't really think that competition is really becoming a big problem.

I'm sure there are lot's studies that [indiscernible] immunotherapy and other product that definitely enthuse about this studies and screening also continue to be quite good and increasing.

In terms of our target number of size, we are looking to have in or around 17 or site, including US and Europe and we are about half way there I would say and the reason for that is we have two trials, we tried to place both trials in the same centers and we may have TCRs coming through for lung cancer, one of the indications.

So we want to get a good cadre of sites that are experienced to cell therapy to our products through..

Sarcoma cohort 4, it’s grown quite well actually, I think it’s kind of system into what happens when all the sites come up and running and also they are evidence of activity that’s seen us. So I mean, I can't say more than the fact that approval is going to be finished relatively quick.

And in terms of data, we have to look for responses and we like to look for confirmed responses. So we'll have some data around this by mid next year for sure..

Thank you very much..

Thank you..

[Operator Instructions]. Our next question is from Reni Benjamin from Raymond James. Please go ahead. Your line is open. .

Hi, good morning, guys. Thanks for taking the questions. I guess, just remind me if I’m thinking about this right, but all the studies that are ongoing right now are using version 1.0 and the MRCLS study is the only one that’s going to be using 1.5.

Is that correct?.

Yes, that’s correct that all the studies currently are using process 1.0. The intention is to transition over to the process 1.5 as soon as its available, and it is correct that the MRCLS study would have been – it would have been the first study using solely process 1.5 and that’s still maybe the case in fact. .

And so I guess that leads to my next question.

In your discussions with the FDA, as you decide to move to, let's say, pivotal studies for any of the ongoing programs, will you need to conduct an additional pilot study first with the new manufacturing process?.

No. So that’s a good question. So that’s really the purpose of the comparability studies that we have mentioned today in the call, is to show on in vitro basis that the processes are comparable, so we would not need to do any clinical bridging or additional clinical testing in order to rollout process 1.5 into the clinical studies, right. .

Yes, so it’s just one single set of in vitro comparability studies that are needed and then that will apply to everything. .

And that in vitro studies – because I – correct me if I’m wrong, but in the space in general I thought that there is a lot of discussion on how exactly to design these comparability studies.

Once you do the in vitro test, is that something that that then goes back and is discussed with the FDA, or are you guys pretty much anchored down on what that comparability test is?.

Yes.

No, you’re absolutely right, but this is an area of really active discussion in the field about comparability, but in our specific case, given the specific changes in our manufacturing process which I described earlier, we have discussed this with the FDA and come to agreement about what needs to be done and the basic principles are that it’s just taking – the biggest issue is donor-to-donor variabilities, so we’ll take three donors and just split the A4A [ph] run both processes..

Got it. Okay. .

And that’s agreed-to experiment with the FDA. Yes. .

Got it. Thank you. And I guess just a little bit of a high level question.

Do you think or do you have any evidence that treatment to prior immunotherapies or checkpoints may impact the expression of tumor antigens that your T-cell products are targeting, and maybe related to that, have you seen any sort of an escape phenomenon yet in those that are currently being treated by TCRs or loss of response?.

Gwen and Rafael. We’ll start with Gwen. .

Yes, so lot of this data, Michael [ph], is emerging and there has been data also recently published like from Tony Raebis [ph] group looking at patients have been treated with PD-1 blockade and who then have relapsed and trying to understand the mechanisms of resistance.

They’ve seen of loss of HLA or loss of interferon gamma, the JAK-STAT signaling pathway. And so certainly tumors are clearly – tumors that have been treated with immunotherapies clearly are adapting to them by reducing their sensitivity of the immune system.

We are trying to do studies in the synovial sarcoma study but I don’t believe that we are releasing the outcome of these studies although we are preparing a publication but I can't say that we are seeing some similarities as well and we certainly have published in our Nature Medicine paper and multiple myeloma that loss of the NY-ESO antigen is a mechanism of resistance in a subset of patients.

We also have presented that in our synovial sarcoma studies that there are – there is a patient that has loss of antigen, but I think there are other mechanisms of resistance as well, and so that’s really an intense area of focus for the company right to understand those mechanisms so that we can leverage that understanding what’s the right second-gen in combination approaches to improve the dots and durability of responses moving forward.

.

Yes, I mean, the only thing I would add to that is that we don’t know really what prior therapy including immunotherapies out to antigen expression. There is very little data on that.

And as a consequence, we are – while we’re not yet mandating this synovial study, we are encouraging and consistently sites are complying with it to obtain biopsies for screening of antigens so that we know what the most recent type of the tumor is with regards to expression of the target. .

Great. Thanks guys. And congratulations on the progress. .

Thanks Reni. [Operator Instructions] We will now take a follow on question for Michael Schmidt from Leerink Partners. Please go ahead. Your line is open..

Thanks for taking my follow up. I had a question regarding your upcoming survival analysis on the synovial sarcoma study and I am just wondering if you could provide some context what type of median or survival would be expected in those types of patients that were less than treated with standard of care and those for T-cell therapy? Thank you..

Yes. So the first thing, this is - there are presentations at SITC tomorrow dealing with various aspects, dealing with the second generation, but this is going to be an oral presentation at SITC tomorrow and so it’s going to be a general update on the NY-ESO cohort.

So the survival data again it come from the cohort 1, in other words the original cohort where we really published the - published the data on survival and let Rafael comment on what normal survival might be in the context of these very late stage and maybe that’s kind of patients?.

Yes. I mean, it is somewhat difficult to answer a number because a lot of the series are compiled in multiple, [indiscernible] There are some - more sign of specific and including subset of studies, like the Vector study and some of the more recent products that have been approved like synovial and Lily product, antibody and other.

In general [indiscernible] most of the series, you know report survival in order of 12 to 14 month and you know the title horning to these questions, we are looking at the series from our patient that had screen negative and haven’t comment to our trial to see really what the survival was.

Obviously it’s not randomized data, but it’s probably going to be one of the best sources that we will have in terms of - help patients to live the standards of therapies. And we hope to have that data once we finally report on this type of study to put our results into context.

But for now I think the year is sort a benchmark that most people would agree with..

Great. Thank you for the clarification..

Our next question is from Robyn Karnauskas from Citigroup. Please go ahead..

Hey, guys this is Kripa [ph] on for Robyn. She says sorry, she can't be on the call. Congratulations on the - on all the progress, looking forward to update over the next few months. So I had a couple of quick questions.

Can you just give us an idea of when in the sarcoma program we might actually see data I mean, you're going to start screening by the end of the year, so when can we expect to see early data.

And in the sarcoma program, I apologize if this question is already been asked before, what would you need to see in all the cohorts that you are treating and you treat in order to really feel comfortable going into the adjacent trials?.

So in your last question, are you referring to synovial?.

Yes, synovial, yes..

So I think you know, the outcomes that we're seeing now of response rate under our ability definitely I think with all set people judge us as clinically significant and even response rate that are lower than that, given that really there are not really many therapies that consistently give responses in these patients.

And so our numbers you know, tomorrow we will report on this, but the most recent updates that we presented at ASMO [ph] and so on are 50% to 50% responses.

So that at our site even responses slower than that if provided that they durable, clinically beneficial for these patients who normally get a lot of success through conduct system therapies but not very much benefit.

with regards to MICLS study and when we will see an update to be able to report, I think it’s difficult to say, there is a lot of excitement on the site to get going and I think that before it gains, that before we are going to start screening and hopefully, very soon by the end of the year.

And again he will depend on how quickly the patients come in and get enough response data to have a meaningful update. It is open label, so we can definitely make reports on interim data, my sense is that you know we will need about a year or so to our meaningful data around this quality.

So hopefully we'll have enough to report in 2017, but it would have to be towards to the end..

Okay, great. Thank you so much..

As there are no further questions in the queue. I would now like to turn the call back to Mr. James Noble our CEO for any additional remarks. Thank you..

Thanks very much for attending the conference and indeed we're giving such an excellence of questions. And so clear to us that manufacturing is very important and I think the release of the clinical hold mean that we can progress and we're basically very excited about 2017. We're recruiting very quickly in that cohort.

Forward, we just said we got the MBNs alongside as for our future programs and we have a clear path forward with the agreed - with the FDA on the manufacturing issues. So we feel very good about the rest of this year and 2017 and we hope to provide some good data updates over the next 12 months. So thank you very much indeed..

Thank you, sir. Ladies and gentlemen, that now concludes today's conference call. Thank you for your participation. You may now disconnect..