Q1 2020 Earnings Call
Ladies and gentlemen, please continue to hold your conference call will begin momentarily.
[music].
At this time.
All participants are in the listen only mode.
After the speakers prepared remarks, we'll we'll conduct a question and answer session and instructions will be given at that time.
During today's call will will be making certain forward looking statements, including statements regarding expected timing of clinical trials and results regulatory activities future expenses and cash run away and I'll development plans and strategies.
These statements are subject to various risks that are described in our filings made with the securities and Exchange Commission, including our annual report on form 10-K for the year ended December 31st 2019, and subsequent quarterly reports on form 10-Q.
You are cautioned not to place undue reliance on these forward looking statements. We disclaim any obligation to update such statements now I would like to turn the call over to Dr., Charles <unk>, President and CEO of tracker pharmaceuticals stuck at the work.
Good afternoon, and thank you for joining tray comes first quarter 2020 financial results in business update conference call.
I will begin with an update on our pipeline and recent activities following that our Chief Accounting Officer, Scott Brown will review our financial results for the three months ended March 30, Onest 2020.
Finally, we will conclude by taking your questions.
Our primary focus is on our recently in licensed PDL, one product candidate and before map a late stage potential best in class checkpoint inhibitor by virtue of its subcutaneous route of administration.
We expect to begin enrollment in a pivotal study in sarcoma in the second half of this year.
Well into whole map is our lead product candidate. We also anticipate significant milestones related to our three other clinical stage assets in the near term.
Let's begin with a review of our recent meeting with the U.S.F.D.A. last week, where we reviewed and discussed our plans for the pivotal phase two envious our trial, well then to pull them out for the treatment of sarcoma.
As a result, however, it may eightth type B meeting with the U.S.M.P.A.
We expect to initiate the envance start pivotal trial in the sarcoma subtypes of undifferentiated pleomorphic sarcoma or U P. S.
And the closely related subtype of mixed so fibra sarcoma or M. S.
This trial will include one cohort of approximately 80 patients who receive single agent and the format.
And the second cohort of approximately 80 patients who versus real who will receive and before map in combination with your boy.
A second checkpoint inhibitor tardy in the C till they fort receptor that is marketed by BMS.
The trial will enroll patients with U.P.S. and MFS, who are progressed on a single line of treatment and who have not received prior checkpoint inhibitor therapy.
The primary endpoint in each of the cohorts will be objective response rate by resist by blinded independent Central review with duration of response being a key secondary endpoint.
Each cohort will target of 15% response rate.
In the trial is designed to detect a response rate that's statistically excludes the known 4% response rate of both trim. The only approved treatment for refractory sarcoma that includes U.P.S. and MFS.
Yes, you heard me correctly and it is disappointing to report that the only approved treatment for refractory U.P.S. at MFS has a 4% objective response rate.
This is a clear statement add to the high unmet need.
We believe targeting a 15% response rate and U.P.S. and MFS is reasonable.
As Keytruda is phase two trial in U.P.S. demonstrated a 23% response rate.
Furthermore.
Checkpoint inhibition with a combination.
Optivo and your boy more than doubled the Opdivo response rate and unselected sarcoma.
Dual checkpoint inhibition may therefore result in a higher response rate as well deeper and more durable responses that single agent and reformat treatment.
Success in both cohorts could allow approval of end reform as a single agent in combination with Yervoy.
Pardon me success in both cohorts could allow approval of under pulling up as a single agent and in combination with Yervoy.
Which would allow physicians to determine which patients are best served by single agent or combination therapy.
The do arm design also provides for risk mitigation should combination treatment be required for robust responses.
Notably Vms executed a similar dual cohort clinical strategy for Opdivo and I must say high tumors that resulted in our People's approval as both a single agent and in combination Yervoy based on your direct response rate in MSR high cancers.
Not surprisingly key opinion leaders and investigators are very enthusiastic about initiate the MSR trial.
Based on addressing an unmet need and the convenience of skewed subcutaneous dosing.
We expect to open the study at approximately 20 sites in the U.S.
Also of note is that the expected total cost of the end Vistar trial, using our CRM independent product development platform, including paying for the Yervoy.
Is approximately $15 million that will be spent over the next two to three years.
We recently filed and format for orphan drug designation in sarcoma and now that the FDA meeting has been completed we expect to file an idea that will cross reference the existing open R&D for and full map maintained by our partner Threed medicines.
And initiate dosing in the MSR trial in the second half of this year.
Our partner three D. medicines is conducting clinical trials in the U.S. in China.
And in the near future, we expect them to fall into a format for approval in China.
We also look forward to our partners clinical data presentation at ASCO.
The ASCO presentation as abstract three zero to one and it's entitled quote and befall map and advanced tumors with mismatch repair deficiency.
And we'll be part of the immunotherapy developmental therapeutics session.
The after a context are expected to be released by ESCO later today, and we expect to highlight the abstract content in a press release Tomorrow morning.
Our expected timeline for the MSR trial continues to include an interim response assessment in 2021 final response assessment in 2022, and assuming positive data submitting a B.L.A. for accelerated approval that if approved would allow for product launch in the U.S. in 2023.
Additionally, positive data from the initial trial in refractory you PS and MFS.
Could lead to an additional new clinical trial and testing and other sarcoma patient populations.
This could be accomplished by initiating a randomized trial, then reform as a single agent or combined with your voice or another approved cancer therapy for multiple soft tissue sarcoma subtypes.
This trial could also include biomarker directed enrollment based on biomarker analyses that will be conducted as part of the initial MSR trial in refractory you PS and MFS.
We estimate a checkpoint inhibitor market for us and MFS could generate annual revenue of nearly $200 million in the U.S., assuming parity pricing to keytruda or opdivo.
Of course revenue could increase or treatment has expanded into other sarcoma subtypes.
Yes.
We'll turn now to Trc, one or two our second clinical stage asset, which is a novel small molecule inhibitor of the DNA basics vision repair pathway.
That is intended to reverse resistance to certain chemotherapeutics.
The NCR supporting for phase, one or phase two trials that are focused on patients what mesothelioma or non small cell lung cancer.
In addition, our academic collaborators continue to evaluate biomarkers in tumor specimens from Globus someone patients treated they completed phase two trial and the tumor specimens from patients and ongoing Trc, one or two trials with the goal of identifying a protein or gene expression profile the correlates with clinical response.
Data from multiple Trc, one or two clinical trials will be presented at ASCO.
Dr. This was of case comprehensive cancer et cetera were present phase one data of Trc, one or two in combination with chemo radiation for locally advanced non squamous non small cell lung cancer.
Dr. Cox with of city of Hope Medical Center will present phase one data for Trc, one or two in combination with discipline and PEM attracted in patients with advanced solid tumors.
And phase two data for Trc, one or two in combination penetration in patients with mesothelioma refractory to pair of Treximet and platinum therapy.
We don't these clinical trial data provide the impetus for the NCR to enroll in new trial of an enriched population of patients who may be most likely to response to treatment.
We'll now move onto CRC to 53, our third clinical stage asset.
We recently announced that we retain global rights for the development and commercialization of Trc to 53, falling Janssen decision not to exercise its option.
Well the product candidate was not highly active in prostate cancer patients with acquired resistant to access Andy.
Trc to 53 is as active as extend in prostate cancer cell lines and patient derived xenograft models.
Given these preclinical data, indicating trc to 53 may be as active as expanding in earlier lines setting.
We expect the product candidate can be developed and commercialized successfully in countries are prostate cancer patients generally do not have generally do not yet have access to expanding.
We therefore initiated and out licensing process to identify a corporate partner to develop and commercialize trc to 53.
Notably we have established three corporate partnerships in China over the past three years as developed significant relations with Chinese pharmaceutical and biotechnology companies that we hope to leverage to quickly identify partner.
Our fourth clinical stage asset is the Cdseventy three antibody TJ for 309 also known as TJ de five.
That is in a phase one dose escalation study as a single agent and in combination with the centric marketed checkpoint inhibitor being supplied by Roche.
We are developing TJ fourth you're not in collaboration with IMS Biopharma through our first agreement with them.
And we anticipate completing dose escalation and presenting topline data from this phase one trial and the second half of 2020.
In this collaboration Tracphone is responsible for the regulatory and clinical development of TJ for through nine in the U.S. and Europe entry kindness, and Todd receive escalating portions of non royalty and royalty payments if imap elects to out license TJ fourth your nine to a third party in any region outside of China.
Macau or Taiwan.
In March 2020, Imap issued a press release announcing a strategic partnership with Kalb, each index and biologics are kg bio.
Whereby kg by receive what their press release described as it right of first negotiation for exclusive rights to commercialize TJ fourth year nine in multiple Asian African and middle Eastern countries.
For up to $340 million in potential payments to Imam.
We believe that based on the kg bio transaction trick on may be entitled to receive a payment under the TJ for three Oneida agreement.
Although imap has disputed that any payment is due.
On April eight we issued a notice of dispute regarding the TJ fourth you an agreement we signed with Imap in November 2018.
As of today that dispute has not yet been resolved.
We will continue to fulfill our obligations under the TJ for three or nine agreements.
As you know our second agreeing with Imap is a multi product collaboration to develop up to five I missed by specific antibodies in North America.
Pursuant to the bi specific agreement Trey kind of Imap may mutually select through a joint steering committee.
Up to five of IMAX spices that began a body product candidates within a five year period for development and commercialization in North America.
Trey common shares the North American rights of any selected bites of antibodies with IMF for each collaborative program and trade ins opt in rights to in licensed the basic antibodies from imap in certain territories.
In March 2020, we learned that imap entered into two license and collaboration agreements with Aibo bio in July 2018.
On April 8th we issued a notice of dispute regarding possible breach of the bias that agreement, we signed with Imap in November 2018.
As of today. This dispute has not been resolved and we cannot provide a timeline as to when or if we will file a 90 for by specific antibody under the bi specific agreement.
Our capital resources are expected to be sufficient to fund our currently planned operations into the first quarter of 2021.
Furthermore, we amended our agreement with aspire capital.
Under which they are committed to purchase up to $15 million of our common stock at our request from time to time during a 30 month period at prices based on the market price at the time with each sale.
The amendment reset the base price for calculating share sold at or above the market price, which may facilitate fully utilizing the equity line, if we elect to do so.
It fully utilize we estimate this facility would extend our crash runway into late three quarter 2021.
Importantly, our financial runway could further the extended through use of our ATM or shelf registration statement or through non dilutive capital from the license of rights at Trc to 53.
Our success based milestones through our TJ fourth year nine partnership with Imap.
At this time, Scott will provide an update on our financials.
Thank you Charles and good afternoon, everyone.
Research and development expenses were $2 million for the first quarter 2020, compared to 5.2 million for the comparable period of 2019.
The decrease was primarily attributable to lower manufacturing and clinical trial expenses related to the termination of the Trc 105 program in April of last year, along with lower manufacturing expenses for Trc to 53.
General and administrative expenses were $1.9 million for the first quarter of 2020 and 2019.
Our net loss was 4 million for the first quarter of 2020 compared to 7.2 million for the comparable period of 2019.
Turning to the balance sheet at March 31 to 2020, our cash and cash equivalents totaled 14.1 million compared to 16 point Fourmillion at December 30, Onest 2019.
As Charles said, we expect our current capital resources to be sufficient to fund our planned operations into the first quarter of 2021, which could be further center through use of the equity line with aspire capital.
With that I will turn the call back over to Charles.
Thank you Scott.
To recap we are pleased the FDA agreed with the invest our pivotal trial design in endpoints as we believe that to be a fast to market opportunity to provide end before map to sarcoma patients in need of a new therapy as expeditiously as possible.
This is also important to investigators who are very enthusiastic about initiating the MSR trial.
And before we have solves for our quest to license and exciting late stage asset and repositioned the company to Ford integrate and potentially build our commercial capabilities.
Which we eventually intend to leverage across multiple products over time.
We expect to deliver multiple potential value, creating and Buffalo and Buffalo map milestones in the next few months, including.
Following the end before Matt I Indeed.
Receiving orphan drug designation.
And importantly, dosing the end Bossart pivotal trial in sarcoma.
We also expect our partners Threed medicine, and Alpha Mammen colleges to file and format for approval in China in EMEA site, Hi, cancer and present and the format of clinical trial data in Emmis I cancer at ASCO.
Including abstract content that we expect to highlight in a press release tomorrow.
We look forward to providing further updates in the coming months and remain confident that we have the right strategy in place to deliver on our development and business plans for the benefit of patients and shareholders.
Thank you for your time and attention and we are available to answer your questions.
Thank you Sir as a reminder to ask your question you would need to press star one on your telephone. So what are your question press the pound cake.
Please standby, while we compile the Q and a roster.
I show our first question comes from Maury Raycroft from Jefferies. Please go ahead.
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Hi, Hi, Charles Thanks for taking my questions.
First one is just on and buy I was wondering.
Its end, but did not hit your expected, 15% overall response rate in the combo with Yervoy.
And it produces results that are close to the double agent produces results are close to that sorry 28 study.
Pembro in the mid 20% range.
Six months durability, I guess would that be sufficient for approval or do you think theres risky might after Ron another study with Yervoy alone I guess, what's the best reference out there for the combo arm.
Yes, it's a great point mortgage so the reason for the combo are really the current alliance trial would show that Opdivo single agent activity in all sarcoma to be clear not just EPS was only 5%, but the combination of Opdivo and Yervoy in all sarcoma was 16%, which is it's fairly remarkable so if we weren't.
How the trial whereby the doublet.
And before map and Yervoy achieved a 20% to 30% response rate just think would that would mean to patients who currently have a standard of care with the 4% response rate that we clearly meet the endpoint of the trial and we would suspect that would be sufficient for approval.
The reason I say that is yervoy as a single agent has been studied in sarcoma Vactor three separate published studies for Yervoy as a single agent and in each case. It was highly ineffective, meaning almost no response rate whatsoever. So I think the whole community in sarcoma is pretty confident that yervoy by it as a single agent is.
Much is an effective in sarcoma and for instance, much less active in single agent PD, one or PDL ones. So in response to your question. We hope that we see the response rates that would allow approval as a single agent based on say, 15% response rate and also the combination of Yervoy and then before map based on potentially a third.
2% response rate that give us the physicians the most options and treating their patients.
But if we see the combination is really what's needed for significant activity. We would be very pleased that would mean a huge advanced in the standard of care for patients refractory you PS and MFS would set up the stage for additional studies that combination other sub types either potentially in the first line setting because remember more in first line sarcoma.
Docs rubes since response rates about 17%.
So thats why we can see its response rate with that combination in the 20 to 30, maybe 40% range.
That literally would be a revolutionary treatment for sarcoma patients.
Got it and if that's helpful. In so for the Pembro data from Sarcone eight it's that's probably an outlier is that kind of.
What you're thinking second.
Yes, so it's interesting yes.
There are there other studies.
Ups of single agent PDP data ones in yes.
The highest responds very clearly was the pembro date in sort 20, so im not sure it's an outlier, but I do think that.
Real response rate could be closer for this class of agents in the 15% to 20% range Maury.
And I think we'll see more data forthcoming for instance from the alliance trial that will have updated data potentially even at ASCO. This year. So.
In the range I'd say of 10% to 20% I think thats, we potentially could expect with PD, one PD one therapy as a single agents in new PS.
And then in the range potentially double that you expect to the combination what Yervoy again based on the alliance data we're at by Nivo. It be double the response rate of single agent Nivo across all sarcoma subtypes.
Okay. That's that's helpful and then I wanted to ask Dan.
I'd now our relationship.
Just if you can comment on ongoing dialogue and Dave agreements are our breach.
Are there breakup fees involved that that would owed to trade time, and if you could just provide any more perspective on the relationship I think that.
Yes, I appreciate the question Maury.
Again, there are two dispute notice is ongoing at this time and given that consideration we won't provide further commentary beyond what I disclosed in the earnings call Whats disclosed in our current 10-Q and whats disclosed in the current press release I would reiterate though that we remain diligent with respect to running the TJ fourth the online trial we.
I've enjoyed working with lined up on the trial and we'll continue to work and move that trial forward expeditiously.
Got it Okay and then last question also relate to Imap just with.
The study that they announced that they started in China I was wondering if five deserve to be similar patient types like like you're pursuing and down if you can just comment on expectations for whether the data that you report later this year, whether that would be at a medical conference or press release, maybe.
Anything additional or how much data we should expect.
Right, Yes, I know we were encouraged to see imad begin their own study of TJ fourth your line in China.
Would complement our current investigations with respect to data release, I think either as possible Maury I think at this point I would lean more toward a topline data release with respect to completing the dose escalation, which we're well on track to do by end of this year.
Got it okay, thanks, and I'll hop back into queue.
Thanks, Mark it was a pleasure.
Thank you. Our next question comes from at White from H.C. Wainwright. Please go ahead.
Hi, Charles Thanks for taking my question.
Hi, Ed so.
Hi, So just a couple of thing.
On the.
53.
In China, you had mentioned any discussions there.
Yes.
Yes, if any thoughts on if we could see a deal being inc.
This year or in our things being slowed down really because of the pandemic.
As far as getting a deal done in China.
Yes, great question that I think respect to tour Trc two of the to the great advantage. We have is that we have spent so much time in China over the past two years as result of or current partnerships with imap with Threed medicines and with Alpha male oncology.
So what weve engage with partners. We've also met I'd say on on the course of 15 to 20 additional pharma companies are biotech companies in China.
That we can turn to with potential interest in Trc to 53. So once that relations established I think we can leverage that and it's hard to promise anything on deal timing, but we are engaging in a process to engage many companies in China around interest in Trc to 53 and that is a priority in terms of business development. This year.
And we do feel it's.
Something that because of arc is getting relationships, we can manage through the cobot 19 situation.
Okay, great. Thanks Charles.
And just the financial question.
You Aspire goes you had.
18.2 million added that 15 million left in the agreement at the end of the first quarter.
Has anything been done and the.
Between the ended the first quarter and now as far as.
Shares being sold thanks.
Sure No yeah. The 14 2 million remains to be exercised at our option and between the we ended the quarter now we have not yet exercised any additional.
Sure puts too to aspire.
Okay. Thanks.
Thank you had.
Thank you.
Next question comes from Jim Molloy.
Lines Global partners. Please go ahead.
Hi, Charles Thanks, taking my question I had question following up on ads on.
Demick issues and your thoughts on.
Any any impacts in the U.S. and on number of companies if that has to delay trials and does how does the potential delays should they occur.
Pack your cash runway.
Yes, yes, great question, Jim So I think with respect to to the current trial. The TJ fourth your nine phase one trial, we havent seen an impact of.
The the cobot 19 on that trial and Thats, mainly because we opened at four sites and when you have a 3.3 design we have four sites.
You end up having actually sites fighting over the slots to enroll patients. So we were smart to do that I mean, Indiana to for example is one of the sites and they did hold enrollment, but because we had 303 other sites open that didnt, we didnt see an impact and enrollment in that trial.
We expect to invest sorry, I'd point out the following we have been doing calls with up to 20 sites that we expect to enroll in.
To participate in this trial and.
To almost a site I would say.
The sites say it it's business as usual.
In terms of patients coming in yes, they get screened at the clinic door for temperature and if they have a temperature. They would go to the offer an evaluation, but patients get screened at the door. They come in they do their clinic visits as they would before the cobot 19.
We had a lot of concern about this as your your question might have implied but we've been very happy that oncology patients, especially those in refractory sarcoma any treatment and they've been able to receive treatment throughout the epidemic even in areas, where the epidemic has been most fortunate patients have remained on clinical trials there have been more telemedicine does.
But when patients need to come in for treatment they come in for treatment. So so overall, we haven't seen a huge impacted the sites that will enroll patients in the study and we do not expect carbonite team will affect the timeline of the trial.
You can certainly not taking a vacation during this as well.
The question on part of the an injection and we spoke about before was sort of ease injection and how that could be different you to factor. Obviously, if you get a better objective response, that's really all you need as a matter I have to inject it but how would that play here and if it's more equipment more critical data in that you'd have a much simpler method of delivery.
Product.
Yes. Good question, Jim So our goal is to show that this drug has a similar efficacy and safety profile of the PDL one class of therapeutics.
And the differentiating feature as you said is a subcutaneous administration and to be clear. This is subcutaneous administration without an edge been so this is not like taking an antibody and having to mix. It with the halozyme enhance technology, where you will inject say a 10 to 15 Cc bolus subcutaneously. This is a simple to see or less.
Injection that is given in the arm and.
Adam in lower back, it's it's very different in that sense.
And so we feel this is a major advance.
Don't have to come into an infusion center incident, a chair to get this therapy you literally could receive this therapy as part of an outpatient visit at your enter clinical and colleges literally you come in you see oncologist much like you are I go into see our general practitioner and we get a flu shot that could be the simple paradigm for use of unfold.
In the clinic.
Beyond that there's also the potential to then do home dosing.
Patients dosed Lovenox and home they obviously dose insulin at home again for this trial to be clear. Our plan is to have this drug dose by healthcare professional but longer term. This does have the potential to be administered by self administration again, given that is fairly straightforward to ccs are less injection subcutaneous an.
Easily accessible.
And atomic regions.
Thanks for taking the questions appreciate it Jim Thank you.
Thank you.
Next question comes from Jim Birchenough from Wells Fargo. Please go ahead.
Good afternoon, it's a nickel Jim salesman.
That's helpful as congratulations on that and the sole NAV agreement.
Question Feather in your cap to get that trial designed.
On that.
Could you go to the FDA, but the suggestion for the combination.
What was that something today.
As an agreement.
During the discussion process.
Hi, Nick I appreciate the question I mean, the reason we we're so pleased with the meeting with the FDA. Nick is we propose the exact trial design that they agreed to we felt that that combination arm as I mentioned briefly in some some prior comments really could revolutionize the care patients not just view PS and MFS through the data we expect to produce for this trial, but.
Intentionally even in larger and other sarcoma subtypes. So that was I think the real joy to us and and I think yes, the great part of the interaction with the FDA that the FDA was.
Very collaborative respect to understanding our our goal here to really meet this unmet need understanding that the combination therapy could potentially be the best way to increase the response rate in refractory, you'll see us and MFS and offered very helpful comments.
But agreed with the scheme the endpoints the eligible patient population all the key items that are needed to implement this trial.
Okay. Thank you and then.
Is there any off label usage.
PD, one or other checkpoint inhibitors.
We intend to kind of popular patient shell study.
No. It's a great question, Nick it's very I'd say dependent on the investigator. So there are clearly investigators that are using for instance, keytruda in you PS in refractory disease I would say those that do user restricted to patients that have PDL one expression.
There are many very experience academic investors that have not yet moved to that level and I would say the many community practices physicians that also.
Don't use as a standard therapy, and you'll see us even if its PD lone positive, but clearly certain academic centers do use keytruda off label and you'll see us.
It's hard to estimate what the overall uses across the entire spectrum of patients Nick but I think it would be overall the great minority of physicians are using keytruda off label in you PS at this time.
Okay. Thanks, and then that's going to also last one on and before the Middle East.
The next there I had a quick look on clinical trial to kind of in the rules.
PD, one combination trials, including major U.S. centers.
It will you be competing school patients at those centers or will you be tilting centers, where there were no active trials ongoing.
Yes, we're actually targeting Nick all the top centers in the US we expect to participate in this trial.
If you consider the sites we used for the tap is strong we had 27 us sites for that study, it's really going to be the majority of those are the similar sites will be used for the end to start trial and yes. There may be other studies going on but to our knowledge. Those centers are not doing a trial, where they are using a checkpoint inhibitor in the rig.
Frac for you PS MFS setting that would compete with this trial and I think thats, an important point I would.
Say, one more time the enthusiasm of the community of investigators for this trial is very intense and a pleasant thing to encounter. So so no. We don't feel there'll be competitive issues at any of these sites and to be clear. If there was a competitive issue. Some of these sites could open the trial. So in other words the top centers if there is.
Study for the exact same population as a study that's already opened they won't opened roll your study and we have not encountered that issue at all with respect to the the 20 or 21 sites. We expect to enroll this to participate in this study and again they are the credit will crime I would say of cancer centers in this country.
That's good sales just to add to that presumably if they had a trial in an earlier stage patient population once they've been exposed to highlight or PD one inhibitor to.
Let me Matt.
It would be in become ineligible field trial.
Oh Thats true if those patients those centers are seeing a first line patients on a checkpoint inhibitor trial to your point, they would not be allowing for this trial.
I would say this Nick that the majority of patients we expect to enroll in the refractory setting at these major centers. Many of them. We'll have received their first line therapy elsewhere. So bill get doxorubicin therapy say in a community oncology setting because that's been kind of what everyone gets once they feel that thats, the timeframe, where they come to them.
Our specialized clinical care or sorry comprehensive cancer center and would be a great person to enroll in our trial.
Okay terrific.
So thank you to work the thanks appreciate it.
Thank you.
As a reminder to ask a question you would need to press star one on your telephone so which are your question press the pound.
Our next question comes from Bert Hazlett from BTG. Please go ahead.
Thanks, just one additional follow up on imap and 43 or non Charles.
Just just to be clear you are conducting that phase one study in the United States and you will be generating that data. That's that's the way. This relationship is continues to evolve right now.
Thats exactly right Breo were fully responsible for the regulatory and clinical development of TJ fourth your nine in the United States.
Okay.
Look for two additional.
Progress.
I know you are sensitive to this but can you say what next steps are in the dispute.
Resolution process.
Yes, I really can't comment further on that deferred yes.
Yes.
Really right now is yes, no preserved our focus right now is the pivotal study for him before Meb I mean, that's.
That kind of the sum up our thoughts is the driver of value for trade content to come out of that Sta meeting with the concurrence and the agreement for the agency around that trial was.
As.
As noted was a great feather in our cap and it sets the stage now for several.
Events over the next quarter that should be culminating in the actual enrollment of the pivotal study.
Yes, we look forward to the and the data and again, thanks for taking the questions.
Thank you very much appreciated.
Thank you.
I show no further questions in the queue at this time I'd like to turn the call back over to Dr., Charles Dauber, President and CEO for closing remarks.
Well, we thank you for your time and attention today, and we look forward to speaking with you again next quarter.
Ladies and gentlemen, thank you for participate in today's conference call. This concludes the program you may now disconnect.
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