Q4 2019 Earnings Call
[music].
Good afternoon, ladies and gentlemen, thank you for saying Goodbye.
A reminder, this call is being recorded today is Thursday February 27th 2020.
At this time I would like to turn the conference over to.
Chang.
Senior director of Investor Relations of Immunomedics.
Thank you Sarah before we begin I'd like to remind everyone that during this call will be making forward looking statements made pursuant to the private Securities Litigation Reform Act <unk> 1995, such statements may involve significant risks and uncertainties and therefore actual results could differ.
Materially from those expressed or implied on this call.
Since that could cause such differences please refer to all regulatory filings with the Securities and Exchange Commission.
Well that's on the call today, we just prepared remarks about the base, that's a day executive chairman.
Hi, Mike Chief Financial Officer, and Chief Business Officer also on the Gulf of queuing, They it's Brendan Delaney Chief commercial officer.
Going to put prepared remarks, we will open the call up <unk> questions. Thank you.
Thank you Charles good afternoon, everyone and thank you for joining us.
The foundation, we laid in 2019 2020 promises to be an exciting year for immunomedics, our top priority for 2019 wants to resubmit, a high quality B.L.A. for Sacituzumab Koby, T. kind of S.G. and late line metastatic triple negative breast cancer MTN B C to that and we're pleased to resubmitted be lane.
On the Thirtyth.
And received notification from the F.D.A. in December that the being able to accepted for filing with the PDUFA date defined June 2nd 2020.
Consistent with industry practice, we're not going to provide details about regulatory interactions as we are now in an ongoing F.D. review period.
Other than to say, we're pleased with the progress to date beyond that we're keenly looking forward to the FDA action on or before the June 2nd PDUFA date.
It goes without saying that our near term number one priority in mission is the approval of Sacituzumab Koby Teekay.
For all the hard work that has enabled us to reached this point to get us over the finish line.
I'm grateful to my colleagues in manufacturing quality regulatory affairs in safety.
During 2019, we also laid the foundation for a number of upcoming clinical Readouts, let me being beginning with the sand or confirmatory phase three study of Sacituzumab govitecan versus treatment of choice in third or later line empty NBC patients.
It took less than 20 months to complete enrollment of more than 500 patients in the U.S. and Europe into this study.
We attribute the success of the unmet need I know investigators excitement in the ability of S.G. to help patient Warren dire need of new viable treatment options.
Since the end up enrollments in July 29 team, we've been monitoring the number events that will trigger the unblinding of this study.
As of the most recent sweep topline readout remains on target for mid 2020 readout.
Meanwhile, we are witnessing the same level enthusiasm from breast cancer care wells for Tropic, So to a registrational phase three study in hormone receptor positive her to better negative metastatic breast cancer, which we launched last summer.
This prints cancer sub type is about three times the size of T.N.B.C. population.
For patients, who failed hormonal and CDK for six treatments and two lines of chemotherapy. The same unmet need exist I didn't like lined and T.N.B.C.
Given that in this late line setting common to use chemotherapy options offer. Similarly, poor result, right response rates and PFS in the range two to three months.
Comparable to the advanced stage and TNBC patients, we believe a positive ascent readout could bode well for SG entropic, so too which follows a very similar trial design.
How does the same for chemotherapy is under control arm.
Complete enrollment up the target at 400 patients Entropic. So two is expected by the end of 2020.
As previously disclosed this study allows for an analysis based on overall response rate other pre specified subset of patients, which cool could form the basis of a potential extended approval submission.
To further address the critical unmet need for patients with breast cancer in September 2019, we entered into clinical collaboration with Roche to potentially at bonds as GE to earlier lines of breast cancer treatment.
Using its novel cancer immunotherapy development platform morphine is roche's studying S.G. combined with the centric against Abraxane plus the centric. The recently approved uplift for patients for newly diagnosed empty NBC.
In the curative setting our collaboration with a German Brett Scoop, which was announced in September 2019 will assist S.G. as a monotherapy in a multinational phase three study in approximately 1200 high risk patients with Hertwo negative breast cancer, who do not achieved a pathlogic complete response falling standard adjuvant therapy.
These collaborations together with a internal development programs on the school our goal to establish as she has a foundational therapy in breast cancer.
Collectively they are designed to just virtually every stage of treatment in TNBC at the same time bolstering our competitive positioning in HR positive hertwo negative metastatic disease.
Additionally, as a patient focused company I'm proud to announce that working in close collaboration with the F.D.A.. We instituted an expanded access program for NTM B C patients earlier this year.
This program demonstrates our commitment to transform the likes of patients with hard to treat cancers.
Moving on to metastatic Urothelial cancer at the ESMO 2019 Congress last September we reported an oral in an oral presentation interim results from trophy you a one showing encouraging 29% response rate in 35 patients treated previously with platinum based on immune checkpoint inhibitor therapies.
This result was highly consistent with the previously reported clinical activity of SG in this setting.
With the enrollment of the 400 patients completed in October 2019, we expect results from this cohort to be available in the second half of 2020.
These data could potentially support an accelerated approval submission.
We also expect the signal seeking second cohort of 46 ineligible patients to be fully enrolled they did this year <unk>.
Importantly, as in breast cancer, we believe it's choose pebbles efficacy and safety profile could make it a strong combination partner and urothelial cancer as well.
As such today, we're announcing that we brought in trophy you'll want to include a third exploratory cohort of its GE and could trued up in combination in patients with relapsed or refractory to platinum based therapies, but naive to checkpoint inhibitor therapy.
We expect the first patients to be enrolled into very near term.
For earliest stage studies, we initiated the Multicode open label Phase neutral peaks or three study in July 2019, and dosed the first patient with non small cell lung cancer in October.
Since the first biomarker enriched study we have launched a helps answer the question if enrichment for trucks to expression could lead to higher responses.
We hope to a habit preliminary hansard later this year or early next based on enrollment.
And now the early Phase study was launched this month by Dr., Alessandro 17, Professor obstetrics gynecology and reproductive scientists at Yale University, who initiated a phase two study to investigate SG in patients with persistent well recurrent endometrial cancer.
Dr. Centene had previously treated the patient with record and widespread treatment resistant nutrients service carcinoma with a dramatic response and in preclinical studies Dr. Centene found the endometrial cancers, overexposed stroke too and are sensitive to SG.
To help support this robust clinical development activities, we bolstered our balance sheet in December through a public equity offering for approximately $273 million.
We also raised non equity capital in April 2019 wouldn't be license as Q2, EPS medicines for greater China, South Korea, and certain southeast Asian countries for $65 million up front and 60 million to be received upon U.S. Sta approval.
We're also eligible to receive developing in sales look out milestones payments up to 710 million, that's what it escalating tiered royalties the beginning in the mid teens, making the partnership the largest single acid biologics license agreement for chain Greater China to date.
Another successful partnership we intend to to lots you what the promotion agreement with Johnson to provide detailing services for their efforts you have far inhibitor about Bursa. This agreement will conclude at the end of March of this year.
Importantly, the Giants agreement has allowed us to maintain a commercial footprint.
As a result, our commercial team is actively preparing for launch readiness and we believe we are well positioned to commercialize S.G. upon approval on or before the June 2nd PDUFA date.
A few noteworthy updates on building out the organization.
<unk> earlier this month I was thrilled to announce that the let dr. <unk>. Each week has agreed to join us as a permanent chief Medical officer.
The whether it is a highly accomplished pharmaceutical executives with decades of experience and a strong track record of bringing innovative drugs to market for multiple biopharma organizations.
In her new role that Immunomedics, Loretta will lead all research and clinical development regulatory and medical affairs activities.
I've had the pleasure of working with Loretta since the spring of 2019, when she was a consultant for the company.
Under her leadership, we've made tremendous advances across multiple pivotal registrational studies, especially as well as established in collaboration with some of the world's top biopharmaceutical companies in cancer centers to move SG up in line of breast cancer treatment and broaden into other truck to expressing cancers.
Look forward to standing by her side when we unveiled the numerous clinical readouts that lie in the not too distant future.
This evening in a separate press release, we also announced and the honor to have Robert it'll be joining me on Medix board of directors.
Bob joins us at a critical juncture as we're preparing for the first commercial launch pending FDA approval.
He brings to immunomedics over 28 years of biopharmaceutical experience with a deep focus on commercial operations.
Let's see all thereby.
Pharmaceuticals until its recent acquisition by Lundbeck previously served as the Chief commercial officer of Juno Therapeutics, where he helped guide the organization through a period of rapid go an ultimate between 9 billion acquisition by Celgene.
Prior to Juno about spent 15 years that amgen, leading the U.S. oncology business.
The BA from the University of Virginia, and an MD it from Harvard business School.
Finally, our objective remains to how the CEO in place a head of commercial launch and we're optimistic to me that goal.
And with that let me reiterate the 2020 is going to be an exciting European immunomedics, we have a number of key events were planning to have including potential commercial launch of as June the U.S.P. ascent read out. The trophy you were one topline read outs and completion off topic, so to enrollment and without.
Obama.
Thank you made that.
As in past earnings calls I will provide topline results here and now that you referred to our annual filing as well as our earnings release. This afternoon for additional details.
As noted by base that moments ago, we expect to receive a $16 million payment from Empress upon the potential approval of S. SG into U.S.
In addition, even though the Jensen agreement expires at the end of March in terms of revenue, we are eligible to receive royalty and milestone payments based on bell persist sales throughout 2020.
Total cost and expenses were 91.5 million for the quarter and 325 million for the year ended December 31st 2019, compared to 87.4 million for the comparable quarter and 235.4 million for the year ended December 31st 20.
The increases were primarily due to an increase in R&D expenses, mostly attributable to activities related to preparation for the approval and commercial launch SG for patients with at least two prior lines of treatment for Mt. NBC in the United States, and CRL remediation costs, including outside manufacturers organization services cost in it.
Hosting services to improve our manufacturing and regulatory function.
The increase in R&D costs were partially offset by decrease in G. any expenses, which is primarily due to decrease legal and advisory expenses resulted from reduced reliance on outside legal counsel as well as a decrease in other and consulting services, partially offset by increasing labor costs.
Net loss was 99.6 million or 50 cents per share for the quarter ended December 31st 2019 compared to a net loss of 93.5 million also 50 cents per share for the comparable quarter ended December 31st 2018.
The year ended December 31st 2019, net loss was 357 million or a dollar an 84 per share compared to a net loss of 310 million or dollar 74 per share for the year ended December 31st 2018.
As of this December 31st 2019, we had 613 million cash cash equivalents in marketable securities.
The number of outstanding shares was 213 million and the fully diluted count was 225 million.
We believe our projected financial resources are attic adequate to accelerate commercial launch readiness pending FDA approval of S.S.G. into United States, an empty NBC continued to expand the clinical development programs for SG continued scale up as manufacturing and manufacturing process improvements and general working capital requirements.
This concludes our fourth quarter and full year 2019 financial results operator, Please open the call up two questions.
Thank you ask a question you would need to press Star then one on your telephone.
All your question please press the pound.
Please standby, while we compile the culinary roster.
Our first question comes from the line of Tazeen Ahmad with Bank of America. Your line is now.
Good afternoon Ah Thanks for taking my questions guys.
Maybe beside I'll ask you with the one that I've been getting and downs on the most switches.
What the assent study such a read out I'm not too long lets say topline not too long after your producer for S.G. why do you still it makes more sense still think it makes more sense for associates to approve the drug on time by the PDUFA versus waiting a little bit longer just to see.
Topline data and maybe you could also walk us through what work what needs to be done once you've got the topline data to deliver all the detailed information the agency as well thanks.
Sure. Thanks to the question to Xen. So first of all that's really not on me or my decision whether to wait for that date or not it's the FTC decision, obviously, but I.
I think our timelines are pretty clear the producer is pretty clear and I can.
Sure. Your mid 2020 is somewhat after the June 2nd day, it's actually quite hard to predict exactly when that event when the triggering event will occur we're getting closer.
By the day, but at the same time, they're not very many events that remain as a result.
If you will the error bars around when that triggering event will occur is not necessarily narrowed and by extension of our topline read out we have a sense of roughly when it might come but it's it's it's subject to a lot of so variability obviously ultimately based someone to triggering event occurs.
So I think the timelines are pretty well laid out and are brought the communicated included the agency and so I think if you know the PDUFA June 2nd dates stands and I will really refrained from for the commenting on the dollar compared with the agency.
I'm, giving you know sort of ranges with respect to the work that remains.
Your once we hit the triggering events that has to get adjudicated. So we will be notified.
By the local.
That's meant and then the batches the last set of sort of patients get shipped off to the central that you'd occasion.
And it's only on based on Central adjudication that we will then called the advent of having occurred which will then trigger and a series of state Oh clean up.
It's by RCR role you.
You do a data assessment that data base assessments and try and reach a.
If you will a quality database at which point you can lock at its usually a probably iterative process because the very first time.
You do such a data cut or not the difficult sorry, a database assessment you will find a a larger than acceptable number of data gaps and then the field force goes out to collect today comes back yeah. That's it written and read iterative until you reach the points off an acceptable database.
And at that point, the databases locks and within a few weeks the topline results will become available.
That whole process is is not an in significant undertaking.
Beyond that complying with information is providing that to the left is generally another four to six months.
Once it's put into the right format than.
Sean to to the appropriate gateways to the FDA.
Okay. Thanks appreciate it.
Thank you operator.
Our next question comes on the line.
With Cantor Fitzgerald. Your line is now open.
Good afternoon, everyone and thanks for taking the question I'm focused on that's it doesn't matter right thing maybe bent on if you can help us understand you know given its being tested in different population.
How are you thinking one of the pricing with ongoing bladder cancer triple negative breast cancer lung cancer studies.
Oh sure on maybe I'll have Brendan comments here.
I will note that obviously will refrain from providing pricing in fact, we have an established the pricing but.
You know friend to maybe you can walk through sort of the puts and takes so the various aspects of our dialogue and debate around yeah. I think up so we've been doing a lot of work obviously on pricing since.
We're going back 18 months and we continue to update our pricing research for room.
I think you know obviously, we feel were in a very strong position. When you think about what the main levers are you know the the unmet need obviously in triple negative is very high our value or are the patient populations relatively small and our value proposition. We think is is very strong. So in the initial launch I think our positioning is is is strong I think.
Thank you.
We continue to follow analogs and that's that's all I'll say without commenting and you know we we do that continuously but we also but we also keep in mind. We we think our drug has play in many indications and we keep all of those indications in mind for a future planning of how a price at launch would would play into those indications as well so well.
Without a you know.
Providing any further detail I think that's kind of our our general approach to pricing at this point.
Thank you very much and just one follow up on you to kill cancer now if I understand correctly that get Trued up Campbell, there's been I own naive, but it will be books chemo, if that's correct.
Can you say, what's the rationale of going after post chemo setting and not in front line.
Well chemo is still the mainstay therapy for the first line in that setting and then generally patients go onto either checkpoints and obviously, we've seen data from checkpoint. In addition to E V. Most recently.
Yes, I think it's gonna be hard to unseat chemo into very near term until we have established the rolled in combination with keytruda.
So that's the logic behind that.
Thank you, Matt and I thought I mean.
Thank you. Our next question comes from the line of Michael Smith with Guggenheim. Your line is now open.
Hi, guys. Thanks for taking my question question on the tropics, Oh, two study Oh I think.
As I already talked about potential we are here from the us and for solid.
Can you just remind us what Steve.
In the chewed negative.
Patient population right, that's not a catch up.
Okay.
Sorry.
Yeah Michael.
The bar with respect since you're referring to regulatory bar.
Really I think the agency rarely if ever establishes an absolute number what I would say that the unmet need is very similar.
Chemos in this setting have shown high single digit double digit response rates two three months PFS.
And our data essentially no not very much as the same as the triple negative population in that setting for the chemo arm and our drug in metastatic breast is shown essentially very similar response rates and PFS is albeit on single arm data as we did for triple negative so both the chemo side of the.
Question It looks the same as well as the activity side of SG look the same.
Keep in mind.
Compared to the current et cetera approval path, where we are filing on single arm data on response rate and duration. That's part of the application. That's in front of the FDA. This interim readout will be randomized response rate between active and control long so it's not necessarily a ball.
Our per se because it is a randomized controlled study and you're going to get a response rate on both arms.
And if it is sufficiently differentiated it would fall in potentially the basis of an extended approval because that makes sense is that clear.
Thanks.
Oh, you mentioned.
Two new studies.
Right.
Setting.
Just.
Right.
Yes.
<unk>.
Yeah. So as you know those studies are being run by the partners in the case of Infinity by a astrazeneca indicates of.
Centric by Roche and so they control the timelines, but they are absolutely landon.
At least in one instance, I think with a indicates approach we expect Q1 or imminent startup that study, but we don't control the timelines.
Thank you.
Thank you.
Our next question comes on the line Matthew Harrison with Morgan Stanley. Your line is now.
Hi, everyone. Thanks for taking my question. This is caught I mean on for Matthew So one correctly on the metastatic Urothelial. When do you think you would have initial data for a and you see in combination with Keytruda and then just quickly versus Seattle genetics and format for don't and I guess, how is that going to inform your invest your invest.
Even in a urothelial cancer going forward. Thank you.
Oh I'm, sorry, it's really too early to judge exactly when data comes but I think though unmet need is pretty dramatic can.
Based on our asked you to ask could you interactions. There's there's tremendous demand in support for this arm to open so allow us to get into it. We expect first station to come on therapy I think.
In March so once we got to handle on how enrollment goes, but we'll certainly be able to provide some timelines with respect to when the read out would occur, but I'll follow sort of similar trials in the past and they don't extrapolate at least for now what the.
Yeah, what the timeline could look like between first patient and then when data might be available in this case. So a lot of excitement. So hopefully enrollment will go somewhat as swiftly.
With respect to.
The data are all vivi certainly impressive data.
In many regards I think there's clearly a potential areas of differentiation in particular on the safety side and duration on therapy. All of this is really cross talk comparisons and those are hardly a perfect. So all I can report back from ask would you is that we really didnt sense any change in <unk>.
Interest and excitement for our program and ultimately if our data recapitulates and we can get through and et cetera approval pathway.
You know, we would probably follow very similar path that Hebei is as follows. The there is absolutely reasons believed that our drug works.
After he be ahead of easy and vice versa, given that we're targeting different antigens Im with you. So as a result, I would hope and thinks that the.
Approval path is still open.
Despite there being other agents available already.
And that's sort of the where the hypothesis under which were operating.
Where our discussions currently are with the agency.
Great. Thank you.
Our next question comes from the line of field.
With Cowen and company.
Nine is now open.
Good afternoon. Thanks for taking my questions a few follow up questions on clinical trials first <unk>. Michael's question on the tropics. You are two interim can you give a sense when after enrollment completion.
An interim could be triggered and so when it when we could see those results.
So I'm, a little countries, which study I'm referring to.
There are two part yes, the trouble so yes, I just sort of since you follow my thought you're on the you would see though.
The interim we have not disclose but it's in a subset of the patients and once we have better visibility into the enrollment it's going I would say ahead of schedule on the enrollment side. So stay tuned and we'll provide that update but it is a response rate assessment. So it would obviously come well ahead of any.
The ultimate full enrollment in trial readout, sorry, not full enrollment, but the full readout of the trial.
In light of just the.
That's helpful. And then second you did mentioned a number of investigator sponsored studies. There's two there were aware of that you Didnt mentioned I'm. Just wondering if you can discuss them. One is I think it's called the Neo Star study, that's looking at Sacituzumab as a new attribute therapy that was recently post that clinical trials dot Gov.
Any information there and then the second is there's discussion about a study at Dana Farber, just looking at the combination assessed to some having keytruda.
We can actually find that when I close trial stuck Rob is that is that a real study or is that.
It was rumors on founded.
[laughter] yeah. So both of these studies, we have not announced here I think they're not rumors they are based on reality, but.
Yep.
You might know until all the contracts are fully signed and the final thoughts are put on the eyes in the T's are crossed a we're not in a position to announce it I think in one instance, the study I think you're referring to was actually discussed by one of the investigators with.
Some of the folks out there won't be we've had that question be brought to us but it is in fact the study of the intent is to study our program in combination with the PD one.
And you're going to be the cats out of access with Keytruda.
In the frontline setting of T. NBC in one case and in metastatic breast or hurt too.
Positive or negative or positive setting and the other capable frontline combination with checkpoint.
And then the other study again that you mentioned the first one of the new idea event CNBC is again or is this study that we hope to initiate and we're in the final stages. So please allow us to sort of be all signed off from all sides and then being a position to maybe released that publicly.
Okay, Great and my question for me just on the manufacturing inspection associated with the refining to be right.
Has that occurred and.
I'm going to comment on that what is your disclosure Stretchered posted an inspection will you.
Well you disclose when it when it happened or will we just have to wait for that the PDUFA date.
I think it's the latter fill on unless there's some very material updates. So we feel that pressing need to provide I would look forward to the to the FDA action on the on the beach refiled be other.
Perfect. Thanks for taking my question.
Thank you Phil.
Our next question comes from the line of Chris Howerton with Jefferies. Your line is now open.
Great.
Yeah. Thanks for taking the questions I think most of my material questions were asked at this point, but you know the it was mentioned in the press release that you're looking to invest more in the pipeline for the other egcs. So just curious what if any plans we might hear about updates, particularly I think for CRC was the most advanced.
I remember in the past I'm. So any update you could give us on the pipeline would be appreciated. Thank you.
Yeah, Thanks, Chris It's certainly been.
Our intention and desire to start investing in the pipeline obviously, our focus had been on the quality operations and the re filing for the majority of <unk> 2019 at Thats, where most about manufacturing activities were focused on a in parallel we're very interested in moving 130 forward.
Which is the 80 see that you're referring to in colorectal what was going to be the first syndication.
Frankly, we're still limited from manufacturing standpoint, as our facility here in New Jersey dedicated to Sacituzumab and we are looking to bring other capacity online CMO think third party Cmos that would take on the manufacturing. So <unk> from the time, we actually trigger the investments and you don't have the contra.
Actually the time, we have material. Unfortunately, the these legacy to take a bit of time to manufacturer and go through the whole R&D process.
But but stay tuned and that is certainly one of the developments news flow will be perhaps quiet, but nevertheless, it's laying the foundation for the future of the company beyond this cheap.
Great. Okay, and then maybe just a quick follow up any updates in terms of the tech transfer in the scale up at Samsung Biologics.
[laughter].
Everything remains on track the intent is as we've discussed previously to have a P.S., which is what that formal fighting mechanism is called to have that are ready and to to be able to.
Submit that as close as possible to the FDA approval of S.G. when you need the approval before you can do that but there's also some work left.
Generally everything remains on track and everything we're seeing where we're delighted to see but.
We don't need it urgently and they're already going as a new jersey should be able to deliver drugs to the market for the very near term call. It. The first 12 to 18 months or so as we said previously based on our projected demand needs and we are comfortably within that timeframe as of now obviously lot of that subject to future developments in all getting after.
Okay approval of Samsung, but a knock on wood things are progressing well.
Excellent okay, well, thanks for taking the questions and congratulations on the creditors.
Thank you very much.
Our next question comes from the line of Paul <unk> with Goldman Sachs. Your line is not open.
Hi, This is cringing guns on for Paul I'm, just wondering if you could remind us what percentage of patients non small cell lung cancer Overextension, Joe and to what extent, that's currently diagnosed or test at four.
So couldn't Tonight on parts you cannot remind you as we don't actually know that number I'm. That's part of one of things were looking to establish as part of this topic. So three study.
But so far what I would say I mean, we're dealing with a relatively small numbers. Although the numbers are growing that we're getting a sense of where that is and Ah I was sort of bookended, a with a probably north of a quarter and south of 75%. So you know almost comfortably where you wanted to be or not.
So rare that it's irrelevant and not so frequent that may be enrichment won't improve on the previously board signal, but it's really too early to note on either one whether it is in fact in that range and what the results would be.
And I have unfortunate lost track of your second question.
No surprise.
Well, it's to what extent the is that test, that's where well what does things kind of Texas.
I wouldn't it is not part of its kind of panel that the validated test only became available very recently so a this would become something that you know if it plays out over time would certainly have to make its way into the testing paradigm, but it's not part of the sound of panels currently.
Okay, great. Thank you very much.
Thank you.
Our next question comes from the line of Shane Shane with Nierenberg capital.
Your line is now open.
Hi, This is I'm only bought neuron for Shanshan. Thanks for taking my questions on <unk> question about the Minnesota can you see market size Oh, So first channel genetics, one day approved easy they say did that the size is about 2000 to 4000 patients and on your corporate presentation results at 8000, So just wondering if.
You could please walk us through your assumptions for the market size.
So solid you want.
Hi, guys. This is a summer.
You can find these numbers in our corporate deck as well, but in the third line setting.
The numbers range around eight to 10000 patients overall now if you're talking about two to 4000 for CE Gen that may be.
That may be the number that they're going after but the told the market size, it's bigger than that.
So I think you quoted 8000 I think that's that's approximately where we're we're lining as well.
Okay, and the number that you would expect to be able to Joel.
That is known addressable market out there as we know today.
Okay, great and insights ask a follow up for tropics. Three can you just remind us if this isn't all comer trial or a few enriched enrollment based on shops to especially mobile.
[noise] no certainly this is a trial that enriches for trop two levels.
Okay, great. Thank you.
Thank you.
Thank you. Our next question comes from the line of Jim Arch enough with Wells Fargo. Your line is now open.
Hi, Thanks for taking the questions. This is the yen and dialing in for Jim just a couple of quick wins on the newly added a CPT naive cohort in the trophy you old one study how how did you determine the size of that cohort.
This is just a explore it's for tree arm or does it have to the potential to become more national study.
Lastly, it looks like from the clinical trial itself site that the clinical sites number a it was reduced from 70 240, So just wondering.
What what other reasons for for removing some of the site. Thanks.
Hi. This is this something again, so I think if you're looking at Clin trials that GAAP, you'll see that.
The first stage of the trial is recruiting 60 patients. It is Simon to Sue to stage. So based on the results from the first stage, we can expand a cohort for potential registrational or pivotal.
Study at that point.
The reduction of decided it's just a bar are better experience with what the sites to recruit at.
Got it very helpful. Thank you.
Thanks very much.
At this time I wouldn't like to handle the conference back over to touching for closing remarks.
On behalf of the entire leadership team I'd like to thank you all for joining US. This afternoon, we look forward to updating you in a few jono ongoing progress.
That does conclude today's conference call. You may now disconnect. Thank you wouldn't have a great day.
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