Good afternoon and welcome to the Iovance Biotherapeutics Second Quarter 2017 Financial Results Conference Call. At this time all participants are in a listen-only mode. Following the formal remarks we will open the call up for your questions. Please be advised that the call is being recorded at the company’s request. At this time, I would like to turn the conference over to Franco Valle, Principal Accounting Officer and Controller at Iovance. Sir, please go ahead.

Thank you, operator. Good afternoon, everyone, and thank you for joining us for Iovance Biotherapeutics second quarter of 2017 financial results conference call. Joining me on today’s call from are Dr. Maria Fardis, our President and Chief Executive Officer; Dr. Michael Lotze, our Chief Scientific Officer; and Dr. Egor Gorbicheski [ph], our Vice President of Clinical Science. This afternoon, we issued a press release that outlines some of the topics we plan to discuss today, which is also available on our website at www. iovance.com. Before I turn the call over to Maria, I would like to remind everyone that statements made during this conference call will include forward-looking statements regarding Iovance’s. goals, business focus, business plans, clinical trials plan and results, potential future applications of our technologies, manufacturing capabilities, licensing and collaboration transactions, future updates and cash usage forecasts. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filings. Our results may differ materially from those projected on today’s call. We undertake no obligation to publicly update any forward-looking statements. With that, let me pass the call over to Maria.

Thank you, Franco. This quarter we made significant progress with our robust immuno-oncology pipeline based on our tumor-infiltrating lymphocyte or TIL technology. First, we have reached an important milestone, patient dosing is now ongoing in two Phase 2 trials in metastatic melanoma, and recurrent and/or metastatic squamous cell carcinoma of the head and neck. And we hope to dose our patient in our third Phase 2 trial in cervical cancer as soon as possible. Second, we initiated dosing patients in the second cohort of the C-144-01 Phase 2 metastatic melanoma trial. Third, we reported encouraging interim data in cohort 1 metastatic melanoma study at ASCO in June of 2017. And fourth, we’re focused on engaging in regulatory interactions with the U.S. health authorities. We anticipate filing a clinical trial authorization to start two Phase 2 studies in Europe shortly. We also recently changed our corporate name to Iovance. We believe this new name better represents our leadership in the field and reflects all of our recent advancements in developing TIL therapy for new indications and prior to beginning our clinical trials in Europe. As we continue to grow, we are also to staff up our organization to assure that we can execute on our goals. And with 64 employees today, we believe we have all the necessary functions present, including clinical science, operations, manufacturing, regulatory, finance, biometrics and research. I would like to start by discussing our recently presented interim data of our ongoing LN-144 metastatic melanoma program. At ASCO, we presented data from 16 patients enrolled in the first cohort of the Phase 2 study. The data shows a clinically meaningful outcome of the evaluable patients with a 29% overall response rate including one patient with complete response continuing beyond 15 months post-administration of a single TIL treatment. 77%…

Thanks, Maria. Today we are providing both GAAP and non-GAAP financial information. Our GAAP net loss for second quarter of 2017 was $23.4 million or $0.37 per share. In the second quarter there were approximately $3.3 million of non-cash charges related to stock-based compensation. Our non-GAAP net loss for the quarter was $20.1 million or $0.32 per share. As I indicated, the non-GAAP adjustments are all associated with non-cash stock-based compensation charges. For the second quarter of 2017, we had a cash usage of $18.1 million, ending the quarter with cash and cash equivalents and short-term investments of approximately $129 million. This cash spending was lower than our guidance of approximately $24 million. The lowest spending for the quarter was primarily associated with the timing of payments, which were made after quarter end. For the third quarter of 2017, we’re projecting a cash usage of approximately $20 million to $22 million, which will leave us with a strong balance sheet to continue to execute our clinical plan. I’ll now turn the call over to the operator for your questions. Operator?

Thank you. [Operator Instructions] Our first question comes from the line of Boris Peaker with Cowen. Your line is open. Please go ahead.

Great. Thanks for taking my question and congratulations on the progress that you’re making. So for my first question, I’m just curious for the Phase 2 trial in head and neck and cervical cancer, the product is called 145 versus 144, which was – 144 is in melanoma. How are those two different?

Hi, Boris, thank you for the question. From an operation’s perspective or manufacturer’s perspective they’re not different, they’re under two different INDs for two different indications that’s why they have two different numbers, the process of manufacturing is the same.

Got you. Okay. Thanks for clarifying that. So then switching to the melanoma study, so how many patients are – can you remind us how many patients are second cohort of the study? And more importantly, how similar are those patients to the first cohort? And what is the allowable kind of delta and response rates between the first cohort and the second cohort for you to conclude that second gen are equivalent in assay to first gen?

Thank you. That’s a great question. So both cohorts are allowed to enroll up to 30 patients, the total allowed into the LN-144 program is up to 60. Given that we expected that the responses between the two cohorts would be rather similar, the idea for changing the process in generation 2 was a fairly similar manufacturing process. We expect similar responses. The delta is not statistically to find one, so we’re not looking for bioequivalence or BE per se. We’re looking for approximately similar responses and that’s what we see from our in vitro assays.

Got you. And just my last question, this is more to do with timing. So you’re planning to transfer your first and second gen technology to the European centers in early next year to start clinical trials there, I understand that. But what I’m trying to understand is by the end of this year you should have already decided in the U.S. of which technology gen 1 and gen 2 you’d like to move forward. So why not just kind of wait for that and only move that generation of technology in Europe instead of transferring both of them to Europe?

Very good. The reason is that there is a lead time for tech transfer and we did not want to lose that time. We have tech transfer over here and process of tech transfer in both generation, and we will make a decision by year end and that generation will proceed. But it was more effort to do tech transfer on both of them, but it saves the time now as opposed to wait to make a decision then only then start the tech transfer process. So we didn’t want to wait – yes.

Yes, I understand. Sorry to interrupt. But just to clarify, you’re going to move the same technology generation forward in Europe and the U.S. Is that correct?

Absolutely, yes, it’s the same process.

Great. Well, thank you very much for taking the questions, and again, congratulations on the progress.

Thank you so much, Boris.

Thank you. And our next question comes from Madhu Kumar with Chardan. Your line is open. Please go ahead.

Hello. Thanks for taking my questions. So my first one relates to the third cohort, the retreatment cohort. When you present data from cohort 1 and cohort 2, are patients being kind of automatically enrolled into cohort 3? So kind of following from that, will we expect to see cohort 3 data along with the cohort 2 data by year end 2017?

I’m going to ask Egor [ph] to comment on this. Egor?

Yes. Thank you, Maria. As we discussed previously, the cohort 3, it’s a retreatment cohort for patients who are eligible to be enrolled, so we do not hold them, we transfer those patients and those categories that we’ll define in the protocol.

So from a timing perspective in terms of reporting on cohort 3 versus cohorts 1 and 2, cohort 3 really may do answers in more of a scientific question, while cohorts 1 and 2 are more of a process development sort of a question. Which process is the one you would like to expand upon? So they’re not necessarily in the same bucket, we expect – we’re looking forward to seeing the data from cohorts 1 and 2. Of course, if you have a significant improvement in cohort 3 that would be something we would incorporate into our program as well.

Okay. And then kind of following, thinking about the process similarities or differences between 1 and 2, how do you think about the timing for the regulatory path forward? So when you have data for both cohort 1 and cohort 2, whatever it looks like, when we could understand kind of what is the strategy for kind of the target population, at least the first time for the treatment of metastatic melanoma?

Certainly. So target population is something we have defined slightly better in our current amendment of the protocol, it is posted on clinicaltrials.gov, its patients that are progressed on the entire PD-1 therapy. In terms of the interaction with the agency, a second piece that we are looking forward to have is the manufacturing method and which one is our selected choice. I have previously commented that our intent is to try and initiate interaction with FDA before year end, and we remain on that intent – internal plan. So that’s when we are planning on having the discussion regarding confirmation of the patient population, the clinical plan, as well as our manufacturing plans with FDA.

Okay. Great. And then kind of thinking more generally, what were your takeaways from the AdComm for Novartis for their CAR-T therapy? What that speaks to in terms of personalized T cell therapies, both smaller from an efficacy perspective, but more from a manufacturing and process perspective?

I actually felt that that AdComm was particularly helpful. I think you could see FDA being particularly open for unmet medical need to receiving a fairly small package of patient population. And approximately 70 patients were submitted as part of the package, and the agency was certainly open to receiving that as a DLA package, so that particular portion was quite encouraging to me. On the CMC portion, I think it gave us some clues in terms of the number of fleets and manufacturing regions that they would expect to see as part of the DLA. So I thought that in general the agencies particularly open and receiving new applications, new cell therapies for the existing unmet medical needs. I thought it was a very favorable interaction in general and I think the outcome of the AdComm devote certainly shows that as well.

Okay, thanks very much.

Sure.

Thank you. And our next question comes from the line of Joe Pantginis with Rodman & Renshaw. Your line is open. Please go ahead.

Hi. Good afternoon and thanks for taking the question. Maria, I’d also like to focus a little bit on the recent outcome for 019. But from a different standpoint a large part of discussion was also focused on the safety especially – generally for these CAR-Ts even though this is a great advancement but does bring a lot of focus to T-cells. Has there been any change say post outcome with regard to any of your clinical sites or potential physicians with regard to the more benign safety profile of the TIL approach.

Yes. Thank you, Joe. We certainly haven’t discussed – and although we’re having a brief discussion about CAR-T, we certainly haven’t discussed the adverse event profile with our clinical sites regarding others products. But what I can focus on is TILs have a different safety profile as you’re completely aware and given dose in hundreds of patients for some number of years. I think our clinical sites sort of appreciate that and they have absolutely the necessary support as needed for patients that are being dosed with TIL subsequent to a dose of chemo as well as IL-2. So these sites are highly fluent in this type of an administration, we are very confident in their ability to care for patients. But we really haven’t had a direct dialogue with them in terms of what they’re doing in cooperation of other people’s products. But I appreciate what you’re saying. I think there is a component of site preparation involved as these cell therapies are entering the market.

No, that’s helpful. Thank you. And then my quick second question is I guess more housekeeping. I just wanted to verify with regard to the EU studies are those the ones associated with your collaboration with Karolinska.

No, actually thank you for asking. I was referring to two in-house Iovance studies melanoma and cervical studies are expanded to be entering into EU and in anticipation for that we had a health authority interaction in EU and Germany and we have received their feedback, our clinical trial authorizations are in process or being prepared. And PharmaCell is being used to provide cells that are necessary for patients that are being as part of Iovance studies in EU.

Great. Thanks for clarifying and thanks for the questions – answers.

Thank you for your questions. Thanks, Joe.

Thank you. And our next question comes from the line of Biren Amin with Jefferies. Your line is open please go ahead.

Yes. Thanks for taking my questions. Maria, maybe if I could just start on the cohort 2. What’s the timing to enroll the 30 patients? And do you need to enroll all 30 patients before you go to FDA on next steps?

Thanks, Biren for the question. We have not provided guidance in terms of timing of enrollment, it is certainly something that is not entirely in control with the sponsor, you know as failures may happen in otherwise. But I don’t think we need all the patients, of course, the more the better. There is a certain internal minimum criteria we have defined for ourselves before we go to the agency. But again, we think that some of the data at the level what we saw at ASCO would give you enough of an indication as to what type of responses you may or may not be seeing the cohort 2. So I don’t need – for most of us internally, we don’t need to have all the 30 patients enrolled, we can certainly make the decision based on a little bit more preliminary number of patients.

Got it. And then just on the European study, will you look to mimic the Netherlands cancer institutes TIL trial, where they’re comparing it head-to-head against YERVOY?

The specific studies where we are going to Europe are our existing on going two of our three trials. So the two studies are LN-144, which is going to Europe as well as U.S. as well as LN-145 in the cervical indication. So it would be the manufacturing method that’s developed at Iovance which is being tech transferred into PharmaCell just for studies instead of U.S. only are going to be run in the U.S. and EU. So it’s not a global Phase 3 study, existing ongoing studies that we are expanding into Europe.

Got it. Thank you.

Thank you.

Thank you. [Operator Instructions] Our next question comes from the line of Mark Breidenbach with Oppenheimer. Your line is open please go ahead.

Hi, Maria. Thanks for taking the question. Just a quick one for me regarding the two ongoing investigator sponsored trials that are being run in combination with PD-1 inhibitors, the NCI trail and Moffitt trail. Do we have any updates on when we might see the first slices of data from those two studies?

Hi, Mark. Thank you for the question. The NCI study, which is a PD-1 combination is being run under supervision of, of course, Professor Rosenberg. Professor Rose, we have asked the question of whether he would be interested in publishing sort of early preliminary data or he prefers to have larger number of patients into the program. And he clearly prefers larger number of patients into the program. So I expect in his case he might wait until he has more patients before he puts the data out. In terms of combinations that we have with Moffitt and we have a few of them now, the specific study that we are aware of is the AP combination study where Moffitt is in fact has written a manuscript for the number of patients they had into the program and they have submitted for an online journal at the moment. We have not seen the manuscript published yet. So I will not comment about it until the manuscript is actually released.

But there was a 12-patient study being run by Moffitt in combination with OPDIVO?

Yes. That one is currently still ongoing, a melanoma you are referring to.

And that just recently started enrolling patients?

That’s correct. The in vivo combination study is still ongoing, so I don’t expect that they will be putting that data out quite yet.

Okay. All right, thanks.

Absolutely. Thank you, Mark.

Thank you. And I’m showing no further questions. And this does conclude today’s Q&A session. This also does conclude today’s program. Ladies and gentlemen, thank you for participating in today’s program. And you may all disconnect. Everyone have a great day.