Q2 2019 Earnings Call

The region expire <unk> second quarter 2019 earnings conference call.

At this time, all participants are in listen only mode.

Later, we will conduct a question and answer session and instructions will be given at that time.

As a reminder, this conference call is being recorded.

I would now like to turn the call over to Mr., Derek Gambro, Vice President of law and policy for rejects bio you may begin.

Good afternoon, and thank you for joining us today with US today are Ken mouse, which had expired president and Chief Executive Officer, Dr., Steve Nicola Chief Medical Officer, and that's just our Chief Financial Officer.

Earlier. This afternoon, we just filed released financial and operating results for the three months ended June Thirtyth 2019, the press release reporting our financial results is available on our website at www Dot rejects bio dot com.

Today's conference call will include forward looking statements regarding our financial outlook. In addition to regulatory and product development plans.

These forward looking statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted and can be identified by words, such as expect plan will may anticipate believe should intend and other words of similar meaning.

Any such forward looking statements are not guarantees of future performance and involve certain risks and uncertainties. These risks are described in the risk factors and the management's discussion and analysis section of Regeneron filed quarterly report on Form 10-Q for the quarter ended June Thirtyth 2019, which is on file with the Securities and Exchange Commission and available on the Fccs website.

Any information we provide on this call is provided only as of the date of this call August 7th 2019, and we undertake no obligation to update any forward looking statements. We may make on this call on account of new information future events or otherwise.

Please be advised that todays call is being recorded and webcast. In addition, any unaudited or pro forma financial information that may be provided is preliminary and does not purport to project financial positions or operating results of the company actual results may differ materially I would now like to turn the call over to Kevin Mills, President and Chief Executive Officer Biogenic style.

Ken.

Thank you Sarah good afternoon, everyone and thanks for joining us on todays conference call. We will provide a recap of our recent progress advancing and expanding our NAV technology platform.

Steve will provide an update of our internal clinical programs and then we'll provide an update on financial results for the second quarter of 2019.

Well then open up the call for questions.

Over the course of the past decade rejects Bio's mission has remains clear to improve lives through the curative potential of gene therapy based on our proprietary NAV technology platform.

We believe a single administration gene therapy treatments can significantly alter the course of disease in many patient populations.

And we are committed to our work with these patients in mind.

The past several months have been highly productive that rejects bio.

We've advanced our internal programs onto treatment modalities, Avi mediated antibody delivery and monogenic gene replacement.

Both modalities utilize our NAV technology to develop treatments for those suffering from rare genetic diseases.

And expand treatment options for diseases broadly affecting public health.

[laughter] with clinical development programs across three distinct therapeutic areas, including ophthalmology central nervous system and liver directed we have a broad and deep pipeline that leverages, our NAV technology, which consists of over 100 novel Avi vectors.

Our gene therapy product candidate RG X 314 administered as a one time treatment can potentially help treat millions of patients.

And today, we're excited to announce further positive interim results from our ongoing RG X 314 phase one two way study trial for wedding, MD, which Steve will address in his remarks.

We are encouraged by these data and look forward to sharing more new interim data from all five dose cohorts in October .

Our licensee partners continue to make important progress as well in May the FDA approved the first gene therapy based on regional biotechnology platform. The approval of Novartis is all jan's my marked a significant milestone for NAV technology gene therapy, and patients and families facing spinal muscular atrophy, a debilitating and potentially deadly disease.

Virgin expires Formula for success has always been driven by breakthrough science talented people sound capital and disciplined execution of our plans.

Our decade of commitment to making gene therapy, a reality for patients has transformed us into a global leader in developing gene therapies that have the potential to transform the way diseases are treated.

Today, we are driving an expanding pipeline of internal programs for chronic and rare diseases.

It's an incredibly exciting time, and whereas motivated as ever to realize the full potential of the NAV technology based gene therapy.

So with that I'd now like to turn the call over to Steve for a clinical and regulatory update.

Thanks Kim.

I'm pleased to share advances in our internal programs across optima logic, CNS and liver directed therapies.

I'll begin with our RG X 314 program for the treatment of wet AMD D. A disease that affects more than 2 million patients in the U.S. Europe and Japan.

Patients with wet AMD to usually require anti VEGF therapy as frequently as every month indefinitely to prevent vision loss.

Continual long term therapy with inter ocular anti VEGF injections is a burden to patients and families and many patients struggled to comply with the recommended therapeutic regimen for current anti VEGF therapies, leading to under treatment and ultimately vision loss overtime.

Archie Evthree 14 utilizes the NAV Avi a. vector to deliver a transgene encoding and anti VEGF antibody fab to potentially halt the proliferation of blood vessels in the retina.

As we previously announced we completed dosing for the phase one two way to clinical trial of RG X 314, and went AOMT, which included the dosing of 42 subjects in five cohorts at eight leading U.S. retinal surgery centers.

And reported durable treatment response from Coordthree at one year. After a single administration of RG X 314.

50% of patients in cohort three required no intravitreal anti VEGF injections at one year.

We announced today that these patients continue to be injection free through 18 months.

We are particularly encouraged by these results given the subjects in this study were difficult to treat and had received frequent anti VEGF therapy.

Prior to enrollment in the trial.

We also are pleased to report that at one month, we see dose dependent increases in Archie Ecpthree 14 protein expression levels across all doses.

We expect to report clinical data from cohort three out to 18 months and interim data from cohorts four and five in October of this year.

Last month, we also had a type b meeting with the FDA to discuss our planned phase Twob trial.

We are pleased with the outcome of this meeting which keeps us on track to initiate a phase twob trial in wet AMD de by the end of this year.

Progress continues toward our planned filing of a new R&D for a phase two trial evaluating RG X 314 in subjects with diabetic retinopathy in the second half of this year.

Phase one two ways safety data from the ongoing Rgs 314 wedding DMD trial will be used to support dose selection.

Manufacturing is in process to support enrollment in our GXT 314 trials for both wedding empty anti r.

Next I'll turn to our gene therapy programs for the treatment of monogenic diseases, including labor directed and CNS directed programs.

In our labor directed program, our GXT fiber one for the treatment of homozygous familial hypercholesterolemia, we have re initiated screening and enrollment of subjects in cohort two of the phase one two clinical trial.

We expect to report interim data from cohort two with corticosteroids waxes and the second half of this year.

Turning to our CNS programs for our GXT 121 for the treatment of MPS to screening dosing and activation of additional study sites continues and the first of two dose cohorts in the phase one two clinical trial.

We expect to present, an interim update in the second half of this year.

For our GXT 111 for the treatment of MPS, one subject recruitment and additional site Activations are ongoing in the phase one clinical trial.

For our GXT 181 for the treatment of CLL and two disease, we expect to file an i., Andy or for an equivalent for the first in human clinical trial in the second half of this year.

We will continue our diligent work to drive these programs forward.

And we look forward to providing you with updates on our progress.

With that I turn the call back over to Ken.

Thank you Steve we're very encouraged by these updates and especially the new interim data for RG X 314.

[noise] Progenics bio has an extensive footprint in the gene therapy space and our scientific infer in scientific innovation could potentially bring many breakthrough gene therapy treatments to market through not only our own product candidates.

As well, but also product candidates developed by our licensee network.

And as of June Thirtyth 2019, our technology was being applied in more than 20 partnered product candidates in development by now technology licensees 15 of these partner product candidates are in active clinical development and as I mentioned earlier Novartis is Jens my which uses the Naveen vector has been approved by the FDA. It's currently marketed in the U.S.

Last month, we announced that we added a new now technology licensee with a new worldwide license with Pfizer for the development and commercialization of gene therapy for the treatment of Friedreichs ataxia. The most common hereditary its akcea.

This license agreement further validates the strength of our intellectual property portfolio and we continue to be encouraged by NAV technology in the treatment of movement disorders.

As licensee programs progress and achieve efficacy and safety milestones. They further validate the broad application of the NAV technology platform and provide additional data that collectively drive the advancement of the Avi gene therapy space.

You can refer to our press release issued earlier today for specific updates on other external partners.

And finally to touch on one other update from May.

We announced our plan to construct a cgmp production facility in Rockville, Maryland, the new cgmp production facility will be integrated into our previously announced new headquarters and construction is underway and when completed will allow for production of NAV technology based vectors at scale is up to 2000 leaders using our platform suspension cell culture process.

The facility will be designed to meet global regulatory requirements and is expected to be operational in late 2021.

The creation of this additional manufacturing capacity utilizing our platform process.

Will allow us to more efficiently.

[noise] advance our development programs from research stage to the clinic and ultimately to patients.

This has been a private priority for us to develop excellent people plant and systems and we hold ourselves to the highest standards of quality and the development of our gene therapy product candidates.

We expect our manufacturing network to be capable of supporting early and late stage programs, which may require large scale vector supply.

With that I'd like to turn the call over to David for a review of the financials fit.

Thank you Ken regenerate trial ended the quarter on June Thirtyth, 2019, with cash cash equivalents and marketable securities totaling.

$449.7 million compared to $470.6 million.

As of December 31st 2018, cash cash equivalents and marketable securities as of June 32019 included $32.1 million of marketable equity securities in prevail Therapeutics Progenics Bio's co founder prevail and currently owns 2.43 million shares of prevail common stock pardon prevails IPO in June 2019, regenerate expose equity interest in Brazil had a carrying value of.

$400000.

And were included in other assets on the consolidated balance sheet.

On the completion of prevails IPO, the securities, where we've classified to marketable securities and subs.

Subsequently re measured at fair value the decrease in cash cash equivalents and marketable securities. During the six months ended June Thirtyth 2019 was primarily attributable to $53 million of net cash used in operating activities. During the period, partially offset by the unrealized gain of $31.7 million related to the marketable equity securities of prevail.

Revenues were $7.9 million for the three months ended June Thirtyth 2019, compared to $40 million for the same period in 2018. The decrease was primarily attributable to $40 million of nonrecurring license revenue recognized during the second quarter of 2018 under our amended license agreement with Abaxis.

The decrease was partially offset by revenue.

Recognize during the second quarter of 2019, resulting from license.

Options exercised and development milestones achieved by the licensees during the period as well as royalties on net sales of full gens won't.

Commercial sales of Xeljanz.

Commenced in the second quarter 2019, and we expect royalties to increase in future periods. We are also eligible to receive a milestone payment of $80 million from of axis. Upon the achievement of $1 billion in cumulative net sales of Xeljanz.

Research and development expenses were $29.5 million for the three months ended June Thirtyth 2019, compared to $21.5 million for the same period in 2018. The increase was primarily attributable to increased personnel costs laboratory. So these costs in external expenses associated with conducting clinical trials in manufacturing related services.

General and administrative expenses were $13.4 million for the three months ended June Thirtyth 2019, compared to $8.3 million for the same period in 2018. The increase was primarily attributable to increased personnel costs and professional fees for advisory and other services.

Net loss was $1.5 million or four cents basic and diluted net loss per share for the three months ended June thirtyth 2019, compared to net income.

$10.6 million or 33 cents basic and 30 cents diluted net income per share for the same period in 2018 net loss for the three months ended June Thirtyth 2019 includes unrealized gain of $31.7 million Oragenics Bio's marketable equity securities of prevail recognized during the period.

Based on its current operating plan projects, both expects its balancing cash cash equivalents and marketable securities to be at least $350 million as of December 31st 29 team with that I will bend, the knee and turn the call back to Ken to provide final thoughts and review our upcoming 2019 milestones.

Thanks that that was a good update also although I like Steve's update better.

To summarize what we've discussed today the past quarter marked a highly productive period for the company. We continue to advance RG X 314 through clinical development for the treatment of wet A.M.D. and D.R.

Today, we shared additional positive interim update on the RG X 314 program for wet AMD in which we reported our GXT 314 continues to be well tolerated, we observed dose dependent increases in RG X three one for protein expression across all five dose cohorts.

50% of the subjects treated in cohort three continue to remain free of anti VEGF injections at 18 months and we plan to share more new interim updates from all five dose cohorts in the trial in October .

In addition, we remain excited about the anticipated start of the phase Twob trial in late 2019.

We're also on track to file a new R&D for our phase two trial of RG X 314 in diabetic retinopathy in the second half of this year.

Our regulatory and clinical progress also includes continuing enrollment for RG ex fiber, one and RG X one on one while our expanding research pipeline includes new programs for the treatment of head of credit Terry Angioedema and top of fees, which we are developing in collaboration with Mirimmune.

We're excited by a new strategic direction to include Avi mediated delivery of antibodies to treat diseases affecting larger populations. While also advancing gene therapy programs to treat important rare monogenic diseases.

The recent FDA approval of Novartis is all Jens month based on our NAV technology platform was an exciting milestone that further validates NAV technology.

After a decade of steadfast effort and focus we remain dedicated and committed to improving lives through the curative potential of gene therapy.

Before we go to Q and a.

Take this last moment to recognize the excellent work of our employees partners clinical trial investigators and of course, especially every patient and family who's chosen to participate in our clinical trials.

With our innovative science inspired people in partners and strong cash position, we are well positioned to achieve future milestones advanced therapies for patients with significant unmet medical needs.

With that.

I will turn the call over to the operator for questions.

Thank you, ladies and gentlemen, if youd like to ask a question to our speakers. Please press Star then the number one key on your Touchtone telephone. If your question has been answered or you wish to remove yourself from the queue. You may do so by price from the pound key we ask that you. Please mute your line once you've asked your question to prevent any background noise from coming through as well. We ask that you keep your question to one question and one follow up question before rejoining the queue for any follow ups again, if you'd like to join the queue. Please press Star then the number one key on your touched on telephone.

Our first question comes from many for her with SVB Leerink. Your line is now open.

Hey, guys. Thanks for taking my question.

I have a quick financial one around how to think about the royalty stream from Novartis.

You guys reported license and royalty revenue not breaking out could you could you break out the royalty revenue either gross royalty or royalty net of what you guys are obviously you pan for sales of Xeljanz, thus far.

And if youre not comfortable doing so can you tell us what bar of total royalty revenue you say you think you would reach the materiality threshold, where you would break that royalty revenue.

As a single independent line item.

Hey, Marty Thanks for the question.

Yeah. This quarter, obviously weve recorded as we as Vince described.

Revenues received.

On the basis of Xeljanz Miss sales by Novartis in the license and royalty category of our profit and loss statement and there was not a material gap reason to breakout.

That sale number for this period, because we really had just a fraction of the quarter that involved.

The ramp up of those sales.

I think we'll have better guidance based on what we see in terms of the ramp over the next several quarters for when that breakout will occur and also when that breakout will occur in parallel for the cost of sales or cost of product.

Line item associated with that.

Great and as a quick follow up.

How many like how many patients the data should we expect to see.

At the first HSH data release approximately.

Well were currently operating on a re enrollment schedule for the dose cohort two with corticosteroid profile access that has an nfthree.

And we will have a better sense towards the end of the year of what our progress has been.

But we're hopeful to have data on that cohort at the end of the year.

Great. Thanks, guys I'll hop back in the queue.

Sure. Thanks.

Thank you and our next question comes from Gena Wang with Barclays. Your line is now open.

Thank you for taking my question too.

Regarding MD program can you mentioned that Q4 and five we showed a dose dependent increase in protein expression. Just wondering was that proportionally correlated with that dose increase.

Janet Qs dose dependence means.

Increasing from the previously reported cohorts.

Proportional to the doses that have been.

Used in cohort four and co or five.

Okay. So like say double the dose then you saw double with the protein level.

Yes across all five cohorts will be able to show.

Mean values from patients that one month by the time, we report data that will show that dose dependency.

Okay and then another question as you said three patients that had 18 months injection free.

So could you just remind us what is the criteria for rescue injection and then also can you remind us the injection rate.

12 months prior to this in therapy for these patients.

Hi, Gina Steve here, Thanks for the question so.

It is a key question what criteria you use in a trial and when you're looking at re injection rates of anti VEGF therapy.

In this phase one to a trial, we had a very liberal.

Reinjection criteria, so basically as a principal investigator.

Sees.

Any decrease in visual acuity.

Due to presence of fluid.

For an increase in fluid leading to a decrease in visual acuity bay at their discretion can give a reinjection. So I think it's important to note that that's.

A very low bar for re injecting compared to some other studies that have been done or.

Later stage studies, where you'd have.

Now, let's call it tougher criteria, where you'd need for example, 75 micron increase.

And or a decrease of a certain amount of.

Best corrected visual acuity letter decrease so thats part of why we're so encouraged by these results not only is it 50% of the subjects in cohort three that have not needed any reinjection through now 18 months it's.

In the face of these very.

Low bar for for Reinjection for these subjects.

To the second part of your question, which is also critical how much anti VEGF need.

Exist for these patients since if they didnt need many injections before.

They got gene therapy treatment, you Wouldnt expect many injections after and.

In this case, we have a very anti VEGF needy population that's been enrolled in this trial so.

On average.

Patients have needed 35 injections or more.

Chronically prior to receiving our GXT 314 in the last year.

Well one one point is that as part of the inclusion exclusion criteria subjects needed to have four injections within the last eight months. So already right. There you know it's a fairly.

Injection needy population and in spite of having those injections there was still fluid present at entry into the study.

If we look at a year, we previously disclosed some of this for the early cohorts.

Depending on on cohort, it's anywhere from six to 10 injections.

In the prior year on average.

And we'll have updates on this as well.

Going forward in October when we update on all the cohorts.

Well certainly put it in the context of how much the anti VEGF.

Injection rate was for subjects pre prior to getting gene therapy.

Great. Thank you very much if I can just quickly ask one more question regarding the phase Twob trial design you say in line with Ft could you just remind us what is the Fido trial design for phase Twob.

Thank you, yes, so well.

Later in the year when we give the update on the program. After Weve presented an update on the actual results that we've seen to date the interim results, including all five cohorts will give more details on the actual trial design.

Suffice it to say now based on the successful outcome of our.

Type B meeting.

We're very encouraged on the main elements main design elements of our phase Twob study.

And we had.

Very good constructive.

A discussion with the FDA, so we feel very confident.

Reiterating our guidance and actually our expeditiously even more than before.

Looking forward to move forward with the starting the study by the end of the year.

Thank you very much thanks.

Thanks Gina.

Thank you. Our next question comes from Matthew Harrison with Morgan Stanley . Your line is now open.

Hi, This is close to us on for Matthew I have a quick start adopting a MD could you talk a little bit.

About the competitive advantage that the sofa TXT won four compared to other things head up against that that currently in development. Thank you.

Yes, hi cost us. Some this is Ken I'll start and maybe Steve can provide some additional color.

Steve described the origination of their product candidate, which I think has several important features that are differentiators, including the use of our NAV technology of course to 88 factor, which is highly selective.

For cells in the retina that we want to target for this treatment in wet AMD and other indications that will be responsive to anti VEGF therapy.

We're also using.

The sub retinal route of administration and have initiated and have now completely enrolled a trial that.

To my knowledge is the largest of its kind.

Where.

However, you measure it number of subjects 42 on treatment or number of doses five doses.

And we've also as Steve was alluding to in his response to Gina.

According to our investigators have enrolled in a population that is referred to as the hardest to treat wet AMD patients.

So.

Designing a program at this stage for phase one two way that helps us evaluate pharmacology of RG X 314 in at a true hard to treat natural history background of wet AMD patients and advancing what in my view is the current gold standard of sort of safe and effective route of administration for delivery of Avi to the retina.

Supported by a lot of preclinical and clinical work ourselves and others have done, but also a worldwide product approval.

Really sets up for.

I think a large and important study, where we're collecting a lot of data.

And now what we're seeing also his first of its kind I think in the results, which is dose dependent response and sustained protein expression.

We are among the first if not the only company to evaluate a wet AMD.

Population using gene therapy looking for downstream protein production protein expression. After the gene therapy has been delivered and Transduced and we've demonstrated we announced today for the first time dose dependent increases in protein expression across all five cohorts.

And durability of expression that we previously talked about.

Of out to 12 months.

But durability of effect clinical effect of up to 18 months and we continue to follow patients and we'll have further updates.

Our product candidate and our program is robust and the product candidate in the route of administration of that I think demonstrated to us that there is an important need to advance. This into later stages of development engagement with FDA for us supports our interests.

And we're encouraged by the evidence that we are generating based on the pharmacology of this product candidate in patients with very clear and well characterize wet AMD.

And I'd add that if you think of it in terms of the non gene therapy based.

Developmental programs that are ongoing.

We are.

We're very encouraged that I think these other programs like from Kodiak grade or the granite busy map or delivery system for example.

I mean, these all show and confirm and validate the need for less frequent injection, but they all still are just incremental advances in terms of.

Yes, it's moving in the right direction of less frequent dosing, but you still need the indefinite reinjection refills.

With these different modalities.

And Thats, where.

A foundational anti but Jeff.

Platform like gene therapy.

It is a potential game changer.

And I'd just second what Ken said is in that regard in thinking of gene therapy. We.

We have the gold standard approach for delivering.

Of vector and getting sustained protein expression that weve now shown clinically.

And now showing a link between.

An expression.

On a durable bases and anatomic and functional outcome measures.

Over the longer time horizon horizon.

That is also being seen in the setting of a dramatic reduction in anti bet Jeff.

Dosing compared to the prior need of these patients so.

We again are quite encouraged based on these results to move forward and I'd I'd, probably add one other piece to their profile Thats now emerged clinically, but we established preclinically with our GXT 314, and the route of administration work that we did.

On that Penn and Johns Hopkins, which is.

We have demonstrated that we have a product candidate and route of administration, where we don't need to rule out patients due to.

Risks of ocular inflammation or preexisting neutralizing antibodies.

And nor do we need to administer any oral inflammatory or anti inflammatory and immune suppressive medications.

Prophylactically or otherwise to address those conditions so.

We believe that that provides a much clearer path to understand the pharmacology clinically.

But also a clear path in terms of the market opportunity for this product.

Thank you so much this is very helpful.

Sure Thanks customers.

Thank you and as a reminder, ladies and gentlemen, if youd like to ask a question. Please hit Star then the number one key on your touched on telephone. If your question has been answered or you wish to remove yourself from the queue. You may do so by pressing the pound key.

Our next question comes from Dane Leone with Raymond James Your line is now open.

Hi, Thank you for taking the questions and thanks for the updates on the clinical progress.

First one from me.

Could you update us.

And.

The mean number of injections for the other half of cohort three I think at 12 months at about 2.3.

We'll be providing quantitative updates.

For all the cohorts in October .

Yes, I'm comfortable saying, though that the the findings that were seeing based on the data coming in is very consistent with what we've seen.

At our one year readout, but we'll we'll have quantitative.

Details in our October update.

Okay, and then could I clarify something from the press release in the comments.

In terms of is the follow up going to be different between cohort four and five or are both cohorts going to have a six month follow up.

So we think a six month.

Data is very important.

So of course, if you March forward from when we announced completion of recruitment of cohort five.

If we're updating in October it's just a matter of how many patients.

In cohort five where we have.

At least six month data on.

Okay, I guess I was asking whether cohort four would have a longer follow up than six months or not yes.

Those patients will have been enrolled in the study longer than six months by the time, We report in October and.

Certainly the cohort three we said Weve already got patients on average out to 18 months.

What we want to do Dean at the.

Next announcement of the quantitative data is show those comparisons across cohorts that dose dependency based on one month protein and as much as possible. This six month clinical outcomes, which is which is where we started with this whole package for this trial. When we made our first announcement and where we think the best pharmacology and interpretation of the relationship between pharmacology and clinical effect exists.

Okay, and then one on the DMD program.

It sounds like you're kind of implying that since you have the dose.

Figured out from the wet AMD study.

That the GMI study should basically accelerate potentially get on a parallel path with what Andy which is more of a kind of the traditional registrational approach for the anti VEGF.

Injectable class is that am I, interpreting things right or over interpreting it.

Well for our diabetic retinopathy development plan.

We've.

Discussed our our target to start a phase two.

D.R. trial.

We we feel based on the data that we'll have from the wet AMD study.

A separate anti separate VEGF, driven retinopathy, although it's a different disease process I think we know enough from.

All the different anti VEGF programs that have been done across the different written opportunities that we can utilize that.

Precedent to help us select doses.

For evaluation in a diabetic retinopathy population as well as of course the safety.

Data that will have an tolerability data.

As far as the actual stage of development I mean, we we kind of we think of them independently.

But certainly by having the phase one two data from wet AMD D. I think it puts us in a good position to.

Advance a phase two study already with diabetic retinopathy.

Right right, yes, sorry.

In my mind, it flipped a DMEA for D.R.

And then just finally so into October this is going to be basically like in an event you're hosting versus a medical meeting.

Correct.

Well I mean, our team along with our investigators are evaluating a few options for presentation, including an upcoming events and we'll plan to announce that when we've completed that process and confirmed a final decision date.

Okay, great. Thank you guys.

Sure.

Thank you and I'm showing no further questions in the queue at this time I'd like to turn the call back to Ken Mills for any closing remarks.

Those are great questions almost better than the updates we had today.

Thanks, everyone for participating thanks, operator, thanks for joining us and we look forward to providing you with further updates have a very nice.

Ladies and gentlemen, thank you for your participation on today's conference. This does conclude your program and you may all disconnect everyone have a great day.

Oh.