Q1 2020 Earnings Call

Ladies and gentlemen, please standby your conference call will begin momentarily once again, ladies and gentlemen, Thank you for Cohen. Please remain on your lines. Your conference call will begin momentarily. Thank you.

Hi.

[music].

Okay.

Good afternoon, and welcome to Io events first quarter 2020 financial results Conference call.

At this time, all participants are not listen only mode.

After the speakers presentation, there will be a question and answer fashion.

If you require any further assistance during this call. Please press Star then zero on your telephone keypad.

Please be advised that this call consist of a recording of prepared remarks, followed by a live question and answer session now I would like to turn the call over to Sara Pellegrino, Vice President Investor and public relations and how fast. Please go ahead.

Thank you Howard good afternoon, everyone and thank you for joining us.

On the call today, you have Maria sorry, our President and Chief Executive Officer, Frederic seeking nine our Chief Medical Officer, and Tim Laurie Chief Financial Officer.

This afternoon, we issued a press release it can be found on our website <unk> Dot com, which includes the financial results for the first quarter ended on March 31st 2020.

It's one of the corporate update.

Before we start I would like to remind everyone that statements made during this conference call will include forward looking statements regarding island gold business focus business plan Precommercial activities.

Well trial plans and result.

Actual future applications of our technology manufacturing capability regulatory feedback and died and collaboration impacted Cobiz 19 and future uptick.

Forward looking statements are subject to numerous risks and uncertainties many of which are beyond our control, including a risk and uncertainties described from time to time inner FCC filing.

Our results may differ materially from those projected during todays call.

We undertake no obligation to publicly update any forward looking statement with that I'll turn the call over to Maria.

Thank you Sarah and good afternoon, everyone I'm very pleased to lead today's conference call to summarize our progress made I thought you there during the first quarter 2020, I've seen move closer towards commercializing I've asked hill for melanoma cervical cancers.

I will also be it read our anticipated 2020, kopec milestones, which old remain on track due to a tremendous efforts all the I've asked team in close collaboration with how clinical sites and business partners.

Well I called it 19 has impacted economies globally I event has been able to continue our key business activities, including clinical and manufacturing activities due to the dedication over internal team members and external partners to address the critical need of cancer patients.

And the first quarter of 2020 be continue to advance our tumor infiltrating lymphocytes therapy or killed in pivotal program in melanoma cervical cancers.

We also made significant progress toward our planned biologics license application or be a submission for life of Nuseal and then one four or five later this year, while preparing for the potential commercial launch in 2021.

In addition, getting excited about the recent and upcoming data presentation. That's further highlight the potential for tilt to become a broad platform of cell therapy treatment across all the tumors.

I'd like to first highlights our progress in our lead program life and you saw a metastatic melanoma metastatic melanoma, the common type of skin cancer accounting for approximately 96000 patients diagnosed annually and 7200 deaths each year in the United States alone.

We announced in early January Debbie completed patient dosing approximately three months ahead of schedule into pivotal code for and I'll see one full floors needle one study of life and it'll be surpassed our target enrollment of 75 patients due to increased demand for participation.

We continue our preparation for to be enabling assembling the necessary documents to be used for submission.

On track to meet with the FDA unexpectedly submit the B.L.A. in late 2020.

As a reminder, lessened do still has received both fast track and regenerative medicine advanced therapy or Ormat designation from the U.S.S.T.A., which were supported by the clinical data from core too and then melanoma study.

The protocol for coal before was designed to enroll the same patient population a score to be presented data from poor too and the melanoma study several times in 2019, and we are excited to present and new data cut from core too at the upcoming American Society of clinical oncology I School 20 scientific.

Program at the end of May in an oral presentation.

I have asked as an organization is very focused on the advancement of this program towards submission of the DNA in 2020.

Our second pivotal program, it's Alan 145 in patients with metastatic several caster, we have made significant progress and enrolling new patients in this see one four or five deal for study and remain on track to complete dosing into pivotal program approximately mid year 2020.

We are planning to submit it'd be a later this year following a dialogue with the FDA.

Agency has previously granted both breakthrough therapy and fast track designation for Ellen one four or five.

As I have mentioned before submission of the to be and these are not dependent on each other and each indication maybe submitted separately.

I will now turn to our manufacturing capabilities, which has been a key success for till commercialization.

Second generation or Gen. Two til therapy manufacturing process continues to be robust with a demonstrated success rate all the above 90% in 300 patients.

We believe me have established a solid track record in manufacturing till four patients in need of treatment as you prepare to launch lately, so and on one four or five using just gen. Two process.

In addition, our intellectual property portfolio. Currently includes a total of 12 granted or allowed patents for compositions and methods of treatment in using I have asked hill in a broad range of cancers predated is 22 day Gen two manufacturing process.

At this time manufacturing at all of our key manufacturing organization continues as planned for ongoing clinical studies.

For launch the initial commercial supply will come from our CMO partner, who she Uptakes Philadelphia facility I will note that construction of our state of the arch hundred and 36000 square foot facility remains under way at the Navy yard in Philadelphia construction of I events commercial facilities clean room started in April 20.

20 ahead of schedule. Then you facility is expected to be operational in 2021 to support commercial supply in 2022 until you didn't really meet the demands of thousands of patients.

In anticipation of the launch of life in Nuseal, and then 145, we continue to build a strong team at I. events, but approximately 190 employees across multiple locations.

Our commercial and medical affairs groups remain focused on ensuring a positive patient experience with life and do so during commercialization.

Toward that we are working on the following priorities.

Clinical site engagement in preparation for commercial launch.

Developing other close collaboration with health care professionals, or a CP, who will be handling and administering our product.

Operational excellence, but I event in provision of the product and communication with payers.

We anticipate that sensors with Piper 10 experience and those with key opinion leaders for melanoma cervical cancer will be the initial target for the launch of life, a nuseal and 145 subsequent approval.

In the United States, because he worked with over 20 clinical sites for melanoma and approximately the same number of sites for cervical.

I have asked is targeting to Trina onboard well over 20 sites at launch and we expect to extent additional sites overtime.

Medical Affairs team works with a net worth of treating HCP and patient advocacy groups as short at information about til is available to interested organizations.

On the reimbursement on patient access front, we have continued discussions with private payors and CMS to ensure timely access to til therapy for patients.

An under a patient centric model, we intend to support the patient at every step of the process from initial resection 10 fusion.

We are developing a patient support <unk> with the mission to enable they can do so patients and providers to create a seamless treatment journey by providing support through a single please contact our hub case managers.

No market research on commercial preparation continues we look forward to providing updates at or on our launch on throughout the year.

I would love to now ask our Chief Medical Officer, Fredriksen consigned to provide an update about recent and upcoming data presentations as well as our other clinical programs that idea that.

Eric.

Thank you Maria.

I'd first like to touch upon the reasons American Association of cancer Research, a youre virtual meeting one well collaborators that's more of cancer center, because that's a data until they have manufactured in non small cell lung cancer.

I live in London methods to loosen up a seamless islands. So for the <unk> process similar to the old Gen. One manufacturing process and that's expected to be a proof of concept clotilde in non small cell lung cancer.

We were very pleased to see unless it's too so durable complete responses and non small cell lung cancer, which is such an unmet medical need indication.

The initial data from all such as the foundation for our strategy to investigate or all of them into cohorts of non small cell lung cancer patients and Hell I O V home to zero to basket study and the most recent data from a youre further reinforces the strategy.

Looking ahead, we will keep the uncle has accepted the new updated data from coal to from a C. One full 401 clinical study of FICA Muessle and at the melanoma and then oral session.

We submitted the upstream to fill the illustrates the do ability and result of longer follow up.

I think melanoma patients can you just with a onetime treat those life and meaningful.

As a reminder, the most recent updates on overall response rate or or or was 36.4 person and 66 patients as assessed by investigators.

These data were presented in November 2019 at the society for immunotherapy of cancer or Society annual meeting.

As a a corporate update generate 2020 medium duration of response or do you are full cohort to do not reach that assisting in the house lumps of medium study follow up.

This data and similarly ditch patient population.

So median overall survival may reach seven to eat lumpy. So the results with life and also a highly encouraging.

Moving onto or other studies, we continue to advance to the clinic in additional indications as well as an earlier lines of therapy.

All key activities across all of clinical programs continue and we think the other onetime treatment approach may offer a particularly attractive option for patients and treating physicians.

These studies include.

He will be called to be able to clinical study, which we also referred to as all basket study.

Valuing the broader potential flipped to treatment in earlier lines of therapy for checkpoints, not use melanoma head and neck and non small cell lung cancer.

There was a modest study has two additional cohorts for relapsed refractory melanoma and non small cell lung cancer at least until.

The ongoing see wonderful flies zero three clinical study in head and neck cancer, which remains an important indication of Iowa.

This study also introduces Bluetooth products into the clinic, including 11 wonderful flows money's section with a new proprietary.

In the third generation on Gen three til therapy cost with.

Well as 11, one full slate as one which also a proprietary PD ones. So this until close.

I will now have the called over to Tim to discuss our financial results.

Thank you Frederick.

My comments will reflect high level financial results from our first quarter Twentytwenty.

Additional details can be found in the press release that we distributed earlier.

Well it is in our report on form 10-Q, two be filed shortly with the FCC.

Net loss for the first quarter ended March 31, twentytwenty $69.6 million or 55 cents per share.

Compared to a net loss of $37 billion or 30 cents per share for the first quarter ended March 31 2019.

Research and development expenses were $57 million for the first quarter 2020.

An increase of $26.1 billion compared to $30.9 billion for the first quarter 2019 <unk>.

The increase in first quarter 2020 over the prior year period was primarily attributable to an increase in costs associated with the license.

To the Io Io be 3001, two and a lot from Novartis.

Our clinical trial costs due to higher enrollment growth commit the internal research and development team and increased manufacturing activities.

General and administrative expenses were $13.9 billion for the first quarter 2020, an increase of $4.8 million compared to $9.1 million for the first quarter 29 Ti <unk>.

The increase in first quarter 2020 over the prior year period was primarily attributable to the growth of internal general and administrative team and higher stock based compensation expenses.

At March 31, 2020, the company help $251.2 billion in cash cash equivalents short term investment and restricted cash as compared to $312.5 billion at December 31, 20 like T.

But first quarter 2020 span included onetime upfront license payments and the stocking of critical materials to be used throughout 2020.

Ill now hand, the call back to Maria to review upcoming milestones and to kick off the QNX session.

Thank you all for attending the call today, we look forward to unexciting unproductive 2020 in closing I would like to reiterate that are anticipated milestones all remain on track for this year, including last patient to be dose into pivotal program poor and then 145 for cervical cancer PBM.

They meeting with U.S., Sta melanoma topline pivotal data and DNA submission.

Overall, I'm very pleased but the progress we have made and our continued prospects to become the leaders until development manufacturing a commercialization I will now turn to call over to the operator for questions operator.

Ladies and gentlemen, a to reiterate ask your question. Please press Star then one or your telephone cheaper. If your question has been answered are used to move yourself from the Q simply press the pound <unk>.

We ask that you. Please limit yourself to one question. If you have of course my comment at this time. Please press Star then one or your telephone keypad.

Our first question or comment comes from the line Oh Mara Goldstein from Mizuho. Your line is open.

Thank you very much for taking my question if I could just returned to the A.T., our data Moffett and I'm curious as to how you characterize the similarities between the Moffett child and your own clinical program and that difference is and then just based on the potential timing of filing in Afghanistan.

Nation is it possible to see a potential bailey approval on cervical before melanoma.

[noise] trying to learn our of course [laughter] from a different perspective between MOSFET and I events program. A there definitely is a defense in manufacturing message. The manufacturing method that is being utilized that them off it is a 60 manufacturing process, which is more similar to ionsys Gen.

In one manufacturing.

Well I have answered manufacturing method of course is the Gen. Two which is a 22 day manufacturing process. So there's definitely differences in the process of manufacturing product itself. They're also is a defense in how we treat the the actual till they use a process, which I call a tumor banking model the patients to scene and initially resected.

The tumor that intercepted then a undergoes the process of initiation of P. rep and breadth for Tim manufacturing process in the meantime to patients treated.

With Nivolumab at least four doses are administered and if the patient is progressing a confirmation of progression is conducted and then I know when he then they received their to followed by your bottom up we don't use that process, because you think it process by which to as well as keytruda in one cohort, where we are doing till plus keytruda or go.

Even approximately concomitantly.

I want to study there's two cohorts that we administer till end up one is equal were three eight and that's patient population, but just PD one that either unequaled were three be which is PD, one relapsed or refractory same coordthree, a we administer till plus keytruda in quarter three be they administer till alone let me.

Pause there there are a few other modifications that are different between them off its study as well as I have answers, but those are the high level indication sort of in terms of modifications.

From a indication perspective, I believe the likelihood to be either submitting a melanoma ahead of cervical or concomitantly and both of them or on the table in terms of discussions with FDA.

Thank you very much thank tomorrow.

Thank you. Our next question or comment comes from a line of Peter Lawson from Barclays. Your line is open.

Thanks for taking my questions.

Just as we think about there's differences between your Moshe true Wolfowitz restriction.

Any evidence from your Genworth and this is Jim to about.

They are kind of the depth is for sponsorship potentially good or how it could change to the world. This with the response rates that we could be thinks about if you will take two and then I guess the follow up around that would be when would we see the next one consolidated for me.

Sure. Thanks Peter.

The <unk> since you're not utilizing Moffat manufacturing process, it's very hard for me to compare but allow me to speak to our gen. One versus our own Gen. Two we did publish differences between these two manufacturing methods 62017.

Let me show that use markers being different in our Gen. Two versus Gen. One gen two having better use markers and activity markers as well as a better potency as measured by interferon gamma production. So we believe our gen. Two is maybe possibly slinky, a better products compared to our own Gen. One [noise].

In terms of data from our own basket study, we had initially thought about releasing data earlier on but as as a it's very noticeable from them often study the heterogeneity of the non small cell cancer patients. It's quite broad. So we are currently thinking Debbie you might do you want to have five at least 10 patients maybe before being released the data, but we have no.

Committed to when that would be this study's, obviously open in a ruling and so when we have adequate amounts of data and follow up you're able to present that but we have not committed to a timeframe for presentation.

Thanks much extinguishing.

Thank you. Our next question or comment comes from a line of Jim Birchenough from Wells Fargo. Your line is <unk>.

Hi, guys. Congrats on all the progress I'm a quick quick question a follow up one you you might not be able answer but just on the Asheville presentation from a cohort two for melanoma should we assume that a median duration of response has been reached I'm not asking for the number but just whether the presentation of the updated data suggests.

Immediate has been reached and then just in terms of young cohorts in non small cell lung cancer anything that you're you've learned from them off it in terms of mutational burden and whether you think skewing towards the high mutational burden on makes sense overload mutational burden just wondering if there's any differences along those lines in year one.

Sure. Thanks.

Sure. Thank you Jim for the question.

In terms of ASCO presentation, and thank you for recognizing that the of course, the abstract itself. The totaled only released abstract itself is still under embargo, but all I can say said, we're very excited that ASCO has accepted the update is core to data as an oral session be submitted the abstract obviously back in February timeframe with a longer follow.

Updated that'd be had and be believed that this product offers great benefit as a onetime treatment to patients and so I am not confirming in any way that a median dior has been reached will be a very excited about the data as a matter of fact [laughter] in terms of the non small so data from the response perspective would be so.

It was a as we had seen before it seems like two is able to generated response for patients regardless of their mutational load. It it's able to create a response for patients that have received their teekay <unk> or tyrosine kinase inhibitors and these are patients had had an actionable mutations.

We're really pleased to see that abroad patient population is very much available to til therapy similar to what we had seen in this setting of melanoma I'm. That's been a cervical frankly, so we are we're not quite changing got direction for a non small cell program. We have a broad patient population defined although I I can say that parts.

Central Registrational patient populations are beginning to emerge as you're seeing data for a broad set of patient population. So I'm very pleased to see that they don't have to select it's a popular shouldn't be have a number of different options for the registration program.

Terrific. Thanks Maria.

Thank you.

Thank you our next question or comment comes from the line of Joe.

Pensions Aro from Piper Sandler Your line is open.

Hey, guys I think thanks for taking my questions, maybe sticking with the Moffitt HCR presentation. So the presenting investigator their noted that the trial with design.

By taking the tumor first and then putting onton evoke has a potential concerns about exhausting the T cells with PD one treatment I'm wondering if you could just speak to that and whether you've seen any indication of that across your entire clinical program on all those cervical and all the other studies. Thanks.

Thanks, Joe [noise].

We certainly see that in our killed growth process HM a sample of until that comes from a tumor that might have had exhaustion markers can get reduced needed by the end of the process.

So I recognize that concerned at our entire program as you noted <unk> as a bulk is positioned for a post PD one landscape.

Given that that's more of a regulatory path, but from a.

Ah procedural person in a process in terms of what our till looks like we do see did you have in Asia markers at the end of R. 22 day growth process, so whether that makes up for the tumor microenvironment impact. It's unclear. We havent done the randomized study to sort of control for that potential variable, we're very pleased to see that the till.

Seem to be doing better after a 22 day growth process. So its unclear whether a tumor banking would offer any benefit. It's certainly doesn't appear that way to me as of now.

Okay got it. Thanks, So maybe just one quick follow up here at the ASCO update I'm can we expect another update from independent Central review and then maybe one for Tim.

Maybe you could just speak to runway with current cash on hand. Thanks.

Sure.

So we were not planning on necessarily giving specific details in terms of whatever you're going by investigator or buy or see I'm in terms of ASCO presentation. It is always easier to report an investigator data just because it's more live available. So the viewers can see a more accurate view.

You have things just because investigators read the data very very much in real time.

In terms of runway ill answer for for Tim as well, we have not given cash guidance, we have plenty of cash in hand to complete our pivotal program and submit our BLE there certainly still evaluating our total year spend and we will provide guidance then be habit available to us.

Well, we're very comfortable with this strong financial position that we haven't been had a really strong track record of being able to do financing. So we will provide additional guidance and be habit available.

Okay got it thanks for taking my questions. Thank you Joe.

Thank you. Our next question or comment comes from a line of maximum Kumar from Baird. Your line is open.

Hey, guys. Thanks for taking her question. So first one relates to the ASCO presentations in a following on from Jim's question. So you mentioned the idea of the median duration or spot response being reached but there are other kind of material events that could impact the disclosures such as additional complete response events would that be a reasonable base.

As for updating the melanoma cohort two in ASCO.

Hi, My do thank you put a question.

I think from just.

Perspective of drug development I'm, a drug developer always gives regular updates you know at any opportunity given just to make sure that particularly if the deal. Our continues that this is something that is of interest both to the investor community as well that's the thing to that community. So I wouldn't necessarily think about why would you want to go to ASCO or do you have additional.

The ours.

Not disclosing anything that you probably are not aware of it. This is obviously still under embargo.

But it's an already aware the New York.

Continues its from my perspective, and incredibly favorable scenario considering the last time they'd be read the data was for JP.

Well again, and we had 15.5 months of median study follow up so I'm not necessarily confirming or declining whether there are different.

Sponsors got deep it or not but just the median do you are continuing or not would've been a read enough to go task though.

And then stepping back kind of philosophically thinking about sort of the other programs like heading back like non small cell what kind of a dataset would you feel comfortable with presenting at a medical cost trends to be it online or in person.

[laughter].

I don't know if there's this is there.

What do you have specific item I think that if and a lot of this is a bit objective.

Drug developers, who have been around 20, some years such as myself you look at the data and you decide something is a striking and it's time to put it out I think one of the key pieces for me always is not to disclose too little data, if it's extremely new with the brand new indication.

And then I can understand that but given that the mall for data for.

Shows efficacy of till in non small cell I think the next question is how would you positioned to and what does I have answered shield.

Due in these indications.

Specifically non small cell so for that information I would like to make sure that we have enough number of patients and some degree a follow up before we disclose it so there's not a specific number.

One of which is I have asked this process. So that's a better sort of the scripture on our end.

Bear in mind.

At the Sixtyk manufacturing process initially has a.

There's there's a couple of stuff in there one is the two gross conditions is.

How does optimized as we have now developed at Iran. If it's precisely why the other proprietary methods. This is precisely why we have.

Tool.

[noise] allowed or granted patent for our manufacturing methods because he has certainly learned how to grow til is very well at this point, but there.

There's also second step that is in process for our Gen. One and that's a selection of a sub population of till.

This selection was part of the original Sci process.

We will be had learned a from NCR and they published.

One of the things that can speak to enough spoken before that that has shortened our process.

Yes, again, shortening really comes from a proprietary methods.

The growth as well as various conditions and optimizations W have undertaken.

Great. Thanks for squeezing one more I'm just curious insurance.

And just on the manufacturing side as you approaching your be away as well as building your manufacturing facility what are the some of the things that the FDA.

By comparison between patients treated with Gen two versus some three versus the PD one selected genthree till thanks.

Sure Hi, Mark Thank you for your question.

So what we did our our initial goal when do you were optimizing for Gen. Two was to keep their product profile fairly consistent with our Gen. One product. We had also done some optimization on Jan one and our goal was to keep it very similar profile for our Gen. Three we changed our direction, a little bit and we didn't necessarily.

The exact same product profile. So the process is not very.

It's not a follow on to Gen. Two we changed a process fairly extensively allowing for us to get to 16 day manufacturing process.

In terms of the data presentation, when we get to head and neck.

I suppose so we havent really thought about what would that data presentation look like they're in different cohorts the patient populations fairly similarly defined so when and if we decide to presented I presume, we can present them side by side and people can draw their own conclusions.

Okay. Thank you.

Thank you Mark.

Thank you. Our next question or comment comes from the line of Ben Bernanke from Stifel. Your line is open.

Thanks, very much and good afternoon.

Also trying to understand the market data from a CR and I guess I was hoping that.

Maybe you could you speak to the African CD, we would expect standard of care for Nivo treatment from patient in that setting and I guess, what would your must be a clear signal, Doug can see over and above center care.

From your.

You are long your long studies.

Hi, Ben Thank you for the question. It's a complex question to answer so I'm going to try and summarize it I'm just because there's a lot of different sub populations that are present in the non small cell lung cancer indication. So let me say really high level.

There is there's probably three big sub population, it's a population which is biomarker driven so they have an actionable mutations.

One of 'em EG, a far B RAF rise and others are part of that cohort, they're typically treated with their teekay is frontline checkpoints have not done very well in this patient population as a second line. The response rate is quite low in that patient population and some of these were in the Moffat study then you could see that.

Of course, our primary refractory patients from the immediacy progress and anti PD one as one would expect so that's one patient population.

There is not very good literature in anti PD one in this setting just because they are not very good investigators believe that somewhere around 5% response to maybe at best 10% responses. What is expected from knievel in that second line and that's the best case scenario.

Second so population is patients that do not have an actionable mutation.

And they're PDL one level is high dose patients are expected to respond really well and the frontline setting and in fact then.

Wieland had shown that he had some of those patients and in fact, they were responders one of them being a CR.

Having had a PDL one expression level of 100%. So that patient population is expected to respond well to PD ones in a frontline under the second line. They have a number of options they might receive other PD until I see eyes, such as PDL, one combinations or otherwise and by third line they would have to resort to chemotherapy.

Standard of care in third line is around 9% response rate and a deal our of around 6%.

For tactful based products.

The third bucket of patients in non small cell our PDL one low patients and these patients are typically treated with anti PD, one plus chemotherapy, but just because they don't have a very good chance of responding necessary to to immune checkpoint inhibitors.

This spoken to patients typically receive chemo plus.

Hi, Peter wants a chemotherapy as front line by second or third line. They are out of options and again they have to resort back to chemotherapy, which as I noted is around 9% to 10% response rate and the Dior of around at best maybe six seven months, so do in different settings, when they reach chemotherapy, but just about all of the patients in non small.

So we'll reach that point fairly quickly does that answer your question.

That's really helpful. Appreciate that.

Thank you congrats great exercise as one follow up question just with regards to the aisle to analog program will be 2001.

Just what are the steps to bring this into the clinic and I guess could you also talked about how you plan on developing this.

But that I mean, I've got just a couple of different till programs.

So programs do you see to leverage the 3001 analog first.

Sure.

Yes, so right now we are still in.

Early preclinical stage and we thought that you would be an IND, enabling activities mode around 2021, we haven't completely disclose our development program will be certainly have a plan internally that we are executing to a when we're ready to get into clinic. We're excited about this program of course that has very favorable the product has favorable.

PK PD and IP landscape, that's why we licensed product and but I haven't disclosed in detail sort of what our development program would look like and I think probably 2021 would be a better time to disclose more information about that.

Okay makes sense. Thanks very much. Thank you then.

Thank you. Our next question or comment comes from the line of Ren Benjamin from JMP Securities. Your line is open.

Hi, good afternoon, thanks for taking the questions and congratulations on the progress Maria you might have touched upon this but I'm I'm kind of curious as to your guys choice of combining keytruda with sold versus Moffitt Nivolumab.

Learnings from this data that that might make you.

Started evaluating other.

Checkpoints and when we think about the market.

Even if we look at the end stage.

Not fulfilling cancer more.

Patient population its significance and now in combination with which checkpoints and clearly move up some kind of curious how you guys are part of our thinking about.

Where you feel that the total fit best.

Sure. Thank you for the question.

You're correct, we started with Keytruda I presume you're your question is why Keytruda versus Nivo is that correct is that what you're asking correct. Okay. All right.

At the time, when we started the program where do you see sort of putting the concept together, we expected keytruda plus chemotherapy to be a standard of care in front line and it has in fact that is exactly what has happened. So we wanted to make sure that you're combining with what is called a standard of care.

Of course, we were replacing chemotherapy with till for the early on patient population. So recall that we have two cohorts cohort three a allows for keytruda plus till and core three be allows for till alone in the relapse refractory non small cell cancer patients.

That was the reason for selection of Keytruda as opposed to move all them up.

The market is quite large and I think in terms of placing till one sort of at a very very high level can think about two strategies. The one strategy. We have selected for melanoma cervical at these our initial strategy has been to go into a lead line patient populations for relapsed refractory with unmet medical need.

That allows us to do a single arm strategy for registration and that certainly has worked out really well for us.

Second broader strategy would be not to go to lead line and if I go to earlier line in combination with checkpoint. So this is our rationale for having the two cohorts that we have it allows exploration of both potential approaches going forward.

And just as a follow up kind of based on this on this market data is there.

Any any thoughts on expanding.

Given this basket study to evaluate something like Nibali, Matt and I think in the study.

They looked at patients with progress.

While undeveloped versus in combination any thoughts regarding.

That kind of a design versus just the straight combo.

Mhm.

Before thinking about sort of what next I, certainly would want to see our own data for till plus keytruda and just to see whether earlier line and concomitant administration that would added benefit or not I think it would be very much data driven.

And I think we don't have quite sufficient amount of data for me to speak to that but I understand but your question is on thank you for that.

Thank you.

Thank you. Our next question or comment comes from the long line of Joe Pantginis from H.C. Wainwright. Your line is open.

Hi, Maria Thanks.

Curious I know my question might be a little bit of a reach at this point, but hoping to get some broad strokes I guess first what can you say, it's been the nature of the talks you've had thus far with payers and secondly.

Maybe can you take any broad strokes with regard to.

Pricing structure or are you looking at potential flexible types of pricing indication based or what have you just want to get some ideas of what you might be thinking at this point.

Hi, Joe Thank you for a great question.

Yes, you have had initial dialogue with Payors and.

So far they have been quite open this is a slightly different.

So therapy product on what is already out there in the market.

Also dealing with a different patient population the products that are in the market or for hematologic malignancies and this is really the first cell therapy product for solid tumor. So the initial dialogues really has been to educate to assure that a differentiated safety profile is clear to the payers as well as the potential benefit for the existing patient population.

In terms of pricing, we certainly haven't.

Quite nail down our own pricing position and I think part of this has always been that as the median deal are for the melanoma program continues we'll continue to.

And as you will see an escrow, where we are with this go very encouraged to see the value of the product.

I think that that that by itself has been playing the role into thinking about the positioning of the product itself.

And then that we certainly haven't disclosed whether we're going to have a different.

Indication specific position for the four for the pricing position of the product, we're still evaluating the patient populations under evaluating sort of how we should administer till in terms of different sites and different indications and so I think we can probably update the market. When we have better information to provide we continue.

[music] being very excited about the product and the payers have been very open to dialogue and have been very welcoming and in fact invited us to come talk to them. So this is Ben it's been a great start to the payer discussions so far.

That's very helpful actually thank you very much.

Thank you.

Thank you. Our next question or comment comes from a line of pure malicious from Chardan. Your line is open.

Hi, good afternoon. Thanks for taking my questions I wanted to follow up without some of the questions about the gen three process and select to tell cohorts that I've been added so based on new the experience. Thus far on can you elaborate a bit more about how you think about the path forward, there and expanding to other cancer types potentially and also.

More specifically in terms of manufacturing in terms of the processing the equipment in the overall set updated how different is genthree from Gen. Two as you think about setting up the the internal manufacturing facility.

That's great. Thank you cooler.

Yes, we are quite excited about being able to potentially offer genthree in other indications as well.

Shows head and neck as our first indication because these patients are particularly sick with a fairly short life. It seems like their life expectancies not very long said, we're trying to see if he can offer something that is expectedly.

Shorter and maybe more potent so that was our intent for both gen. Three and selected till from equipment perspective, we are using the same equipment for Gen. Three as we are using for Gen. Two the method by which we using them order order of events may be different but it's the same equipment sit at commercial manufacturing facility can either.

Really be reconfigured for Gen three should be decide to go in that direction.

Great. Thanks.

Thank you.

Thank you. Our next question or comment comes from a line of Baron I mean from Jefferies. Your line is open.

Hi, guys. Thanks for taking my questions, maybe one more question on the ASKO oral melanoma data Maria are you planning to present data from the PD one primary refractory cohort as it relates to the median DLR.

Thank you enrolled about 42 patients from this cohort presented these data last fall and maybe if you could also contextualize as population in terms of what's the typical MPF Allison and median I'll ask in these patients versus a PD, one or relapsed population.

Sure hybrid thank you for the question.

I don't know fee necessarily we're planning on breaking the primary refractory apart.

I think fever, we had a lot of content for ASCO and we felt that that content is probably a really important and we didnt necessarily think about a sub population presentation. So not for any other reason, except that you have a lot of content and we were excited to share all of that as of now we weren't necessarily pinpointing the primary refractory patient population.

Got it less perspective, we have disclosed that metastatic patients in assays for disease have immediate less of approximately six to seven months. That's the best information be confined in literature for our patient population I really haven't seen a very good PFS and that patient population, it's actually not an easy patient population to find report.

On Unfortunately, there, particularly elon they don't make it very far but I think that that outlets of six to seven months is a great benchmark to show what is expected from a stage for metastatic melanoma patient population.

Okay, and maybe one more as you look to filing to be away. What are your thoughts on the Fargo commercial team that you would need.

Sure we've been having that discussion internally and we certainly have internal plans in terms of how to outreach.

How many sites and what is our footprint going to be I'm, not quite ready to share that today with you, but we have our plans nailed down on it. So we think that we have a really broad outreach both for academic settings as well as community settings, and we have plans as to how to broaden that even further subsequent to launch so both of those.

Or in.

In progress and proceeding we already have a commercial presence inside the company of course, I mentioned that you have an expanding our commercial and medical affairs teams and we're very excited about expanding them further by year end.

Okay, and then maybe just the last one what are your thoughts on filing in Europe. If you had discussions with the M&A in terms of what they would require.

Yeah really good topic as well.

Over the course of development as you're probably aware, we have opened a number of Cts in various countries in you in Canada. So we have had initial discussion as part of the DTA process and we have had also local health authority discussions our centralized procedures for you engagement is planned for later part of 2020.

And we are beginning to initiate that discussion with the centralized cgmp body of European Health Authority.

Okay, great. Thank you.

Thank you.

Thank you I'm showing no additional questions in the queue at this time I'd like to turn the conference back over to management for any closing remarks.

Thank you Howard I think there just want to thank everyone for participating today and we thank our patients on patient families for contribution that they made an internal program and stay tuned we are very excited about progress in 2020.

Ladies and gentlemen, thank you for participating in today's conference. This concludes the program you may now disconnect everyone have a wonderful day station.

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