Q1 2020 Earnings Call
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Ladies and gentlemen, today's conference is scheduled to begin shortly please continue just standby. Thank you for your patience.
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And then ladies and gentlemen, thank you for study by as a reminder, this call is being recorded in today's third.
Do they is when they May 620, 20 at this time I'd like to turn the conference over to child chasing a director of Investor Relations Oh Immunomedics.
Thank you Jamie keep all we begin I'd like to me it might be.
This call will be making forward looking statements made to take 65 insecurity indication.
95, such statements may involve significant risks and uncertainties.
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Factors that could cause such a big placing the uncertainty associated with pharmaceutical development indirectly three people thought.
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Difficulty in full property sales revenues and expenses.
Information about the risk and uncertainties based bite you make a metric.
[laughter] campaign with the catching mix factor.
Included in the company's periodic reports filed with Securities and Exchange Commission, including the Companys Annual report on form 10-K, what did you end up.
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On the call today with the pack, we Mark adult a big thought about the day executive Chairman.
Hi, Malik Chief Financial Officer, and cheap it's often so.
Also on the Gulf of Q and they all.
Imagine President and Chief Executive Officer, and Brian Delaney Chief commercial officer for wanting to get back remark you open the call up for questions. Thank you very thoughtful.
Thank you Charles good afternoon, everyone and thank you for joining us.
We answered 2020 with strong momentum.
While the first quarter was primarily focused on competing at the FDA review and executing an ongoing priorities.
Last several weeks I've been monumental for the company.
The hard work commitment and dedication of our colleagues immunomedics over the last three years.
Culminates in its a series of accomplishments establish us as a fully integrated commercial biopharmaceutical company.
The approval of triviality by the FDA exemplifies our commitment to deliver breakthrough therapies to help transform the lives of those <unk> she cancers.
This commitment is further demonstrated by commercial team.
We were successful in making today will be available to people with MTN BP shortening upon FDA approval.
Noted in our press announcement this past one day should Deltic was shipped all specialty distributors last week and the first patients treated with commercial product exactly a week ago today exactly one week after if the April.
Equally importantly, our regulatory a market access teams have already completed the national drug rebate agreement with the sentence for Medicare and Medicaid services as a result of our teams mobilizing quickly for Medicaid specifically states are now generally obligated to carbon fidelity as of July 1st three months ahead of our schedule.
Timeline and the big win for Medicaid patients.
The week bait agreement is also prerequisite for Medicare.
Another key attack this year the early halting of these phase three offense study due to compelling evidence of efficacy across multiple endpoints.
Began the process of cleaning the database, which will result in database lock and ultimately the unblinding of the study topline read that remains on track for me you 2020.
We also look forward to the topline data from the first cohort of 100 patients who were previously exposed to platinum based on PD, one PDL one inhibitor therapies in the trophy you all one study in patients with metastatic Urothelial cancer.
As previously disclosed these data could change potentially supported the late submission for accelerated approval to the FDA, which has recently granted for Dolby fast track designation in this indication.
For the second quarter patient swore platinum ineligible and have progressed after prior checkpoint inhibitor therapy, an abstract containing early results has been accepted for poster presentation at this year's at school virtual meeting.
An additional abstract from a phase one two study of trick LD in patients with previously treated metastatic endometrial cancer has also been accepted for poster presentation at the same conference.
In other clinical developments, we have entered into kind of good collaboration with the Dana Farber Cancer Institute and Merck just study the combination of today will be with Pembrolizumab and anti PD one antibody in two separate phase two studies.
The first study in both approximately 110 patients newly diagnosed with PDL, one negative MTN B C.
These patients won't be randomized to receive the combination of del Dia and Pembro versus two daldry alone.
The same combination of to delve in Pembro will be used in the second randomized study in approximately 110 hormone treatment and chemo refractory patients with PDL, one positive hormone receptor positive hertwo negative metastatic breast cancer.
Both studies will have prime PFS or progression free survival as the primary endpoint overall survival. Overall response rate duration response to clinical benefit rate will be used the secondary endpoints.
Financially the company complete Didnt oversubscribed public offering and we have added approximately $465 million to off balance sheet.
Furthermore, the.
Pulitzer they'll be triggered to 60 million contractual my phone Penn Medicine, our partner in China, who recently announced the approval by the Chinese regulatory authorities to initiate a pivotal phase three study of today will be in M.T. NBC in China, which they begin to plan, which they plan to begin in the first half of 2020.
At this exciting inflection point of the company's growth I'm also pleased to announce the stuff that strong student Ralph has been appointed senior Vice President Global head of manufacturing.
John is a seasoned executive with decades of experience with companies like asked was any Clinton Merck. He brings a strong foundation foundational background and global commercial manufacturing.
John will still have the initiatives that continue to scale, our global supply chain in short supply continuity and focus of cost to goods optimization.
With Johnson Newell Dr. Morris Rosenberg is stepping down as Chief Technology Officer, with a company, which will be affected later in may.
I would like to thank Morris, who was seminal in helping us develop our initial clinical and commercial supply chain manufacturing processes.
Morris will be pursuing a new opportunity closest to the closest was home in the Pacific Northwest.
It is focused on new product development, we wish him the very best in his future endeavor and we're keenly follow this progress.
Thank you Morris I know you're listening.
The Salama will now go over the financials.
Thank you based on as in the past please refer to our quarterly filing as well as our earnings release. This afternoon for additional details our results.
Total costs and expenses were 82 million for the three months ended March 31st 2020, compared to 79.6 million for the comparable quarter ended March 31st 2019 <unk>.
The increase was primarily due to a 4.3 million increasing R&D expenses and a point 2 million increase in sales and marketing expenses, partially offset by 2.1 million decrease in general expenses.
Interest expense was 13.5 billion for the three months ended March 31st 2020, compared to 10 million for the comparable quarter March 31st 2019.
Increase was due primarily to changes in the fair value our debt balances as a result, with the agreement with loyalty armor.
Net loss was 93 million or 44 cents per share for the quarter ended March 31st 2020 compared to a net loss of 87.3 million also 46 cents per share for the comparable quarter ended March 31st 2019 as of March 31st 2020, The company had 540 million in cash cash equivalents and marketable.
Security on May 1st 2020, the company close on its previously announced underwritten public offering of common stock with that proceeds of approximately $464 million.
The number of outstanding shares after the capital raise were 231 million and the fully diluted countless 242 million.
As based on alluded to earlier, we expect to receive $60 million. Some efforts medicines triggered by after the approval of trade that will be we believe our projected financial resources are adequate to support the commercial launch of choice delving into United States in MTN BC could you expand the clinical development programs for Dalbey invest in the broader clinical development up the 80 see platform.
Continued scale up of manufacturing in manufacturing process improvements and general working capital requirements. This concludes our first quarter 2020 financial results and I will pass it back to be done.
Before we open it up for questions a few words to update on the impact the corner virus and then Nick is having on our business.
With a shelter in place recommendations taking effect, we quickly move to remote access and work from home for all non essential personnel.
We have implemented stringent onsite monitoring and as much as feasible on tape undertaken social distancing measures for essential onsite staff, who predominantly all comprised of colleagues in manufacturing and quality operations.
As a result, thankfully operations have been minimally impacted to date.
With respect to our ongoing clinical trials, we get announced in late March that we were pausing enrollments of new patients and activation of new sites.
What it is too early to it to assess the precise extensive disruption to the conduct of our trial. We are confident that the impact will be manageable in particular, the pivotal phase to be a sense study, which completed enrollment in mid 2019 was halted following the independent DSMC recommendation, we anticipate very limited impact from the pending.
The pivotal hundred patient cohort a platinum eligible urothelial cancer in the Trophy you were one study also fully enrolled as of October 2019, and had significant follow up already completed pre cobot 19. So again, we do not anticipate significant impact.
And finally, following persistent request from investigators that faced the Tropic. So to study of today will be in hormone receptor positive hertwo negative metastatic breast cancer. So we'll be resuming enrollment beginning later this month at select sites that have been carefully vetted for their ability to ensure normal clinical trial operations and patient safety.
On behalf of all my colleagues that immunomedics or thoughts on well wishes all those impacted by the core in the virus pandemic.
Further I would like to express our thanks to the workers, who are providing essential services and helping mitigate the disruption to our lives as well as recognize a medical personnel who are combating this disease on the front lines.
I would also like to extend my special gratitude to my colleagues that immunomedics, who continue to work tirelessly towards fulfilling our mission up delivering these breakthrough medicines to patients in need.
As the lines between the days of the week, the evenings and nights and weekends of blurred, we find ourselves often put again, even more hours than prior to the outbreak I understand this phenomena is playing out across all sector and know that also beyond.
Hey, this all pass them.
Operator, please open the call for questions [noise].
Thank you as a reminder to ask a question you will need to press Star then one on your Touchstone telephone to withdraw your question from the Q. Please press the pound key.
They send Bible, we compile the Q and a roster.
Our first question comes from Philadelphia, Cowen and company. Your line is now open.
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Build your apples on you.
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What's going to next question comes to fill in the dealt with in the Doe or with Cowen and company. Your line is currently at Michigan.
Operator, we're getting.
Emails from folks that are having hard time getting on the Q1. A line is there can you check the lines.
If you do it seems like you have to ask Oh.
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Just to confirm if you'd like to ask a question. Please press Star then one on your touched on telephone to join the queue. Thank you.
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Let's move to the Nick's question that question. Please.
Next question, how cute outdoor doesn't.
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Operator, I have a note here that there's some issues with the dial in all found has dropped.
One moment please.
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One moment.
Testing on even for now the next question in the Q as it goes Michael Schmidt with Guggenheim. Your line is now open.
All right that can you hear me.
Yes, yes, we counted wonderful I don't know how much of what we have to say you hurt.
Yeah, I don't know answer to the operator, well anyway. So why don't I just asked the question I'm. The one was tropics to.
Can you.
Really.
Appreciate it.
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You made on.
Enrolling that study and the investigator enthusiasm.
You know some questions money on understanding the read through successful ability of this study from the assent trial and maybe if you could just help us understand.
You know the the timing potentially of the interim analysis that you talked about which is based on response rate and also help us understand how we should think about potential benchmark.
Troll arm in this trial.
Sure Michael Thanks.
But we haven't provided timing on when the into might occur and that was even before a the cooling of iris and demick too cold and it's really too early to judge exactly what happens from your on up until the time when we sold enrollment. This thought initiating you study sites, we were enrolling extremely well and so once we.
Reviewing here hopefully we can begin momentum pretty quickly and that will then inform us when we would takes that interim and as we get comfortable certain you communicate the timeline, but my hope is that the delays are disruptions will be very limited the and then entirely manageable.
With respect to the benchmark what we generally said it's obviously these are distinct patient population of us triple negative on the one had on the other had in the very late line on refractory setting where we're studying this drug and focus so too. So we're told by the physician community that the patient population present themselves with a very similar outlook to the triple net.
Good and community and other chemo options available to them in fact very much the same ones that they would be using in the triple negative opportunity is setting and those are exactly what it combines the control arm witches kept Jana rebel then and then a relevant so as a result.
My expectation would be and based on the literature work that we've done obviously, all retrospective, albeit some of them or more <unk> recent contemporaneous study.
I would expect response rate on the order all high single digit low double digit and I would expect a duration of responses of perhaps three or so on very much similar to the triple negative opportunity now that is I wanted to have any caveat that it based on literature and the feedback we're getting and obviously this is why we're running the study.
Those are generally the benchmarks I would use which is why.
I'm hopeful one day encouraged by this.
Assessment of I forget the C. On the fact that it will hopefully also transferred over to walk to read what folks who will read out of it.
Great. Thanks, then maybe just a question on not sure Delome and the initial experience. So I know I realize it's army Ben.
Sure it amount of time Drax, Ben on the market, but just wondering if he could just share a little bit initial feedback and whether the initial experience has met expectations. So far.
Yes. So how are you say Brendan blaney, yet so I would say so far so good.
Early as you recognized but I think by you know we manage the launch, especially in the first few weeks on Oh hourly basis, and we were meeting all the tactical implementation and things from that perspective. So certainly internally I think we're meeting all our guidelines I think it was important and we announced this drop was avail.
So within days, which was an important.
Hi, milestone that we were holding ourselves to.
Asians are waiting and so yes.
So far so good.
Feedback from physicians as you can imagine physicians are excited for their patients obviously, but the reaction to the prescribing information then.
The support services.
And what we put out there.
Well received so far so it's early.
So far so good quickly.
Okay, great, Thanks, and I'll hop back in the Q.
It's Michael.
Thank you and I will remind her to ask a question you will need to press Star then one on your touched on telephone to withdraw your question press the pound key.
Our next question comes from Peter Lawson with Barclays. Your line is now open.
Hi, Thanks for taking my questions and congratulations.
As we think about the launch what type of metrics do you anticipate.
Hi, doing going forward.
Milestones your sense of internally.
How are you kind of viewing the successful launch.
This is particularly but we think about.
This time of kind of social distancing.
Thank you.
Sure well, maybe I'll start the Peter and then talk behind it also over to Brendan.
And welcome to the to the party here Peter.
For two working with you in the future.
Look at so obviously, we're sort of two to sort of sets of waste answer. Your question. One is zero, perhaps more traditional metrics that we'd be tracking.
Internally and I'm pretty sure went out on a show those a and then.
Obviously, the covert environment. We also put in place a number of new measures that we want to make sure as the policy.
That will be tracking a husband and so to speak to little bit on both of those I think just from what to expect in the near term.
We certainly don't it seems to be providing.
Directional.
Guidance in the near term, it's very very early days.
We need a little more reps under our belt before we're willing to do that on the other had its sort of pretty straightforward, if our prevalence numbers and opportunity in the U.S.
Yeah hold true.
We certainly want to report revenues will also tie that to perhaps number of accounts and we'll get a better sense overtime will the duration of therapy or what the weight.
Average weight and that sort of the actual sort of utilization of 12 years with respect to vials et cetera, all of that will feed into what the overall revenue trajectory might look like as well as on the margins also gross to net adjustments. So very much traditional metrics that we'll be providing visibility into the upper end do you want to comment on any kind of early Ics.
And on the metrics yes.
Absolutely not.
Thank you.
Function, we had pretty robust key performance indicators like that by I mean, obviously sales targets not just the dollar targets, but also the call cost frequently the standard stuff that you would have.
Marketing, obviously measuring some of the promotional programs in that way. It also oxy market access side as well measuring the quality of our access and some of that we may choose to share on waste sensor air China reaction to choose one so all that is in place and and being tracked as you'd expect you walk.
My question on.
Right.
Terminated as a Kobe type of you know kind of look at launch and the metrics I think from that perspective, we're measuring things a little differently because many of our interactions our virtual reaction. So I've heard virtual interactions were a interaction that might face to face and time has been a video conference.
For a teleconference that were adjusting a little bit for that but.
In general I would say.
Please given the circumstances at how our team is executing in this kind of these on time.
Launching a drug within this pandemic and for that as.
We're physicians are excited about the drug and they're making time for our representatives to educate and they're doing it proactively right. So not only are they looking to engage our both proactively.
That's right there also taking steps to if the drug on formulary in their institution and things that you know there is a swell of excitement damaging which frequency. So I think so far so there's nothing replaces a patient interaction I'm, saying.
But we're pleasantly surprised at how effective some of our virtual.
You know kind of means of communication.
Because we didn't plan for it for around a two and a half three months or we had an early start and.
Our teams are able to direct technology from that perspective.
We're doing what we need to do and driving awareness and these early days.
Thank you just a quick Hello, everyone to trophy studies, but more of a yearend retail.
There's a lot to give direct guidance because those because that makes it we're bound by which called for instead will actually take place and when we submitted so as soon as we have that submission will take place and acceptable.
As is conventional around the time of the abstracts releases of at a title releases is one we'll communicate it.
And I see viewed.
Yes, or no virtual conference.
The conference I think you know I think we'd all prefer one of those if they return [laughter].
Okay. Thanks, so much thanks for taking the questions. Thanks.
Thanks Peter.
Thank you and our next question comes from filling the dealt with Cowen and company. Your line is now open character and thanks for taking my questions I'll just for before I think I was cut off just one question on the launch of Tobey I apologize. If this was asked.
Given the current situation are women able to get prescribed for adobe through telemedicine and virtual visits or are there any.
Requirements for reimbursement or whatnot that they actually have to go into the physician's office <unk>.
Can I apologize if you've already addressed this but I'm kind of curious is.
Could it could impact your uptick.
I haven't addressed that specifically, but as far as a patient being prescribed I'm sure. There can be some consoles, which is that reimbursed as you know filled with Oh.
Telematics.
But as far as Asian, obviously has to come into a busy the infusion from what we hear from physician those patient because of the aggressiveness up he then.
You know the urgency and then later line setting a patient are still coming in and being scheduled so I'm as far as how it works and where that can be done potentially even remotely I think some institutions are actually considering that there are definitely consultants element, but infusions need to happen, obviously in a or in the clinic.
Are those those deployments are these schedules from what we hear from me Oney oncologists out there so.
Okay and.
Second questions I'm, a bit tropic somebody at the first listeners fit is going to resume in may what are your latest expectations for women enrollment could complete and therefore, when we could see the.
The interim analysis.
So fill that question was I will answer it again, we haven't said really or previously on the guidance had been yearend full enrollment ever the interim we only need a subset of patients we haven't quantified that and until we get back into the game here with patient enrollment and see what that trajectory looks like eating up.
To the.
Stoppage, we obviously have very strong momentum so we hope to be able to resume that at least in defense as it were opening and once we get a better handle on it we get closer to the timeline, we'll share that overall I hope that we come out of this and make some would get on the phone with you all.
To be able to narrow that down path and give it a cleaner view of what the impact is but my hope is that it will be perhaps as a non or very very minimal impact to prior directional updates that we'd given in terms of enrollment timelines, but it's really too early to assess that.
And last question for me is just on second mine reimbursement in the past.
I mean im extra suggested that the data that you had in house could be sufficient if prisons and medical meeting or published to get Compendia listing and second my reimbursement in triple negative breast cancer.
What are your more recent plants for.
Allowing reimbursement in second line and maybe moving up.
Sure Dolby into the second line, even in the absence of another trial.
Yeah, So I don't I don't recall.
With respect to triple negative talking about face second line data being published for NCCN. We in fact, we're only as part of our IC studying the product in that setting, but we don't have been generated data in second line setting.
What we might have discussed in prior conversations is the fact that the frontline therapy, especially for PDL. One positive patients is now to centric with Abraxane.
And the label as written for Belviq is to five therapies in the metastatic setting not necessarily specifying what kind of therapies that in which seek what they need to be administered. So we are obviously gonna strictly speed stick with a third line or opportunity with respect to how we detailed it based on the label, but whether individual physician light.
And to make the case, that's a patient that seem to fires in the frontline setting because of the combination would perhaps quantify them for belviq and that the insurance companies and except that that's obviously a conversation that they happened between a position than and the reimbursement authorities, but now.
It's not something that we would be.
Promoting.
Got it thanks for taking my questions and congrats again on the partners.
Thank you Phil.
Thank you very much on our next question comes from Joe Catanzaro with Piper Sandler Your line is now open.
Hey, guys. Thanks for taking my questions here and apologies. If these were already asked maybe one first off on the launch in recognizing that it's.
Early days, but but any sense whether.
You are seeing quick switches off single agent chemo head of documented progression onto your they'll be whether physicians are reaching for it very quickly.
Knowing that the poor outcomes that patients may have good with single agent Chemo and then I just have a follow up on on that asphalt presentation.
Yeah, Joe It's Brendan I think it's too early to tell but outside of being very early I'm not sure will based on the type of data.
That will have here, which is basically 67 data at the institution level. We we it's going to be difficult against those type of that type of data now one can speculate overtime as we get enough experience.
Duration of therapy on the M&A it could be very hard to it can be very hard to get into that type of detail on where those patients coming from.
Okay got it fair enough and then maybe one on ESCO specifically on the endometrial presentation can you just remind us if we've seen data for sacituzumab within endometrial, yet how to trail to levels compare in this indication and the data from this cohort actually inform your your decision to include end.
Immaterial in the in the true to enrich basket trial. Thanks.
Sure I don't think we've previously discussed much route endometrial and certainly not the truck to levels that this is a studies that's been done that has an I.S.T. that we sponsored a and it was sort of independent of us, including it as part of our basket. So, let's just wait until we see the data and whether the profile.
Supports advancing it and sort of further development.
It's certainly something we're working these sort of follow here in the near term and decide as we as we get to that point.
Joe just to follow up on that so this is dr. centene from Yale, whose conducting the study [noise] he'll be presenting he's previously published some preclinical results again with tattoos map in endometrial eight you know also talking about expression of choke too in that specific tumor type that you can reference.
Great. Thanks, Thanks, so much and congrats on the progress there.
Thank you.
Thank you in the next question comes from Jim Birchenough with Wells Fargo Securities. Your line is now open.
No so nickel Jim so.
On this newly announced CNBC trials.
Partner with Merck and in doing.
Let's just say a company sponsored phase two trials regime neighbors.
I used from more rapidly.
I'm, sorry, I at least didn't hear the question came a little bit.
Hold on the call could you ask it again true Yeah, let me.
On the newly.
You mean.
Getting feedback on the newly announced MBC trials.
Hi partner with American Dfc, when presumably a company sponsored phase three trial was I used to expand more rapidly into phase three.
Yeah. So.
It's a it's a good question to have one doesn't preclude the other a this is something that there was a lot of excitement by the other two parties to choose to do this study and.
We have already disrupt the financials, but it's something that we generally will provide the dog and its a great way to generate more excitement and data quickly obviously, Santa Barbara it's been a supporter of truth Lv all along and so at this I think is going to go pretty quickly as well, but certainly one doesn't preclude the other and.
Yeah, well as we free up our bandwidth and resources NVS go from one product to the other suddenly something that we are it's a high our radar and.
Look forward to studying and launching the program.
But it's generally always a good idea to get more information or more a signal out of various potential.
Combination partner since this is a one very I think elegant way of doing it without incurring too much.
Expenses on our.
Capital as well as our resources, which are very valuable source.
Okay and.
And then secondly, you have some.
Ongoing trials, which tells entering can be seen refrac or in solid tumors. When should we expect to hear something about those trials.
You're talking about two studies, all sacituzumab and outside of the breast and lung Indic and.
It was you know any idea well.
The choice does the rate of retail he tells Ana.
The.
Yeah PARP inhibitor.
Combination so a combination with yeah, so actually maybe I'll make an overarching statement with respect to all the partner that studies I'm sort of the case of or are you referring to that being conducted by Clovis.
They are they're doing all the war for the time lines, a little bit governed by them in the same holds true in the combination of PDL, one with Astrazeneca with Roche so the timeline, but those instances because they're one by the company's is really governed by them and we kind of any comments on when to.
Well when we might see the data.
Okay.
And then just last one for me and I note in the press release, a you know the recent raised will help and listen the DC platform, including high menu ones. So to your own 40. So.
Well what should we expect is communications about 80 see beyond traditional the.
No I think a unfortunately, the so the early going is a little bit ill.
Pass unexciting in Battle, we first have to now that we are often running in launching hopefully get the other suppliers for falvey on or we can divert attention on the manufacturing standpoint to getting somebody pipeline assets moving Alternatively, we'll be looking for other manufacturing partners that could potentially adding back to the program.
The challenge whenever you have an agency is just the long lead time with respect and making the product and then doing all the Bbq runs and validating the product so.
But a very here from the won't be unfortunately, much news flow other than perhaps as we progress of these early periods of finding the manufacturing capacity and then moving along that's sort of the uptick when do you expect until this product reaches declining.
You know indicates that we do at least have generated meaningful data would perhaps be quickly once we reach that point, but again for the very near term is mostly going to be around the manufacturing.
Slide 10 aspect.
Okay, great. Thank you very much.
Thank you.
Thank you enter next question comes and Roger song with Jefferies. Your line is now open.
Thank you I think about taking a question. So maybe just a couple from me so as I can see for that the newly announced a and now the way September hibernation.
It is a map the combo.
The combo study so seems to your I studied Bose PDL, one positive and negative I'm. Just curious now how do you expect yeah that'd be will perform in both setting, giving you tend to Bose Jim.
And your positive.
Right so.
Today, it's a positive population were studying it in PDL one.
Now I'm going to get the composite of greater than one greater than 1% into triple negative indication, we're looking at PDL one negative patients.
So you have to just make that I just want to make sure you understand the distinction between the two populations want to see a one positive grade, 1% they'll want to let them all.
A triple negative is the less than one site PDL one negative in general I would say that we don't believe but we we only have very limited data, but I don't think prior checkpoint or PDL, one expression levels will be a important marker with respect to activity for del Valle because it's important part with respect activity.
On the checkpoint, but.
Study will hopefully generate some interesting signals to show that first of all either agent. The agents combined will be tolerable and then either agent can contribute to activity.
Perhaps even turn aid in the ideal world and PDL, one negative patients into a responding patients the combination of the too.
Oh, I eat turning a cold tumor hot.
Through perhaps mechanism of a chemo stimulants here.
Got it yeah that makes sense. Thank you maybe another quick question for that Opex.
And I noticed the.
R&D cost the sequentially lower than last quarter I'm just curious.
Well actually about [noise].
We will work in than we do you kind of launching new study and a that indication.
Yeah, absolutely so keep in mind that as the pre revenue company. We we're expensing across the board. So even manufacturing expenses were captured in R&D moving forward as a commercial company obviously the reporting on those expenses will change and where they get reported.
And as it pertains to our development plan I think you know we're pretty transparent about that are there were a number of studies that we launched last year that will be culminating this year and other studies that are are closing out. This year. So on on balance you know, we expect the R&D spend to remain pretty consist.
Then a unless we launched a dish additional new studies choke and the balance the change here on the R&D expenses very incremental really so you don't really see a change there.
Got it yeah. Thank you yeah, that's off I mean think it once again.
Thank you.
Thank you and our next question comes from Matthew Harrison with Morgan Stanley. Your line is now open.
Hi, This is John on fall Matthew Wes on the corner and thanks for taking the question could you help us a.
Teacher, Florida cohort two from you or what study, which will be presented at ASCO.
Yes, what is the question with respect to those patients.
Yeah, so what kind of what level I see we are expecting or.
Yeah that kind of Oh, yeah, what level I I think this would be I think the first time that we'll be presenting data in the study. So I certainly don't want to sort of front run the data presentation. I think generally speaking yet because its population is not going to be that difference to the.
ER to chemo, a eligible population than the frontline setting so I think anything that differentiates in the refractory setting above the 10% himself threshold is there's going to be a meaningful advance for these patients also.
Okay. That's helpful.
Could you comment I need to be more on.
Process offer react TV meeting or size for tropics, Oh two study.
Any specific or beat how the changes your caused corresponding cash.
You mean in relation to the enrollment.
Yes.
Oh the question interest.
What is the impact going to be on I guess I just missed I'm sorry, yes. So.
Just to what I'm, saying is that we are initiating enrollment into the study later this month.
Select sites that we specific every evaluated to make sure that they could actually manage a patient from the very early days throughout the whole treatment period as including all the follow up and.
Safety and efficacy assessments required.
Once we get back into that.
Bodes well get a better sense of what the trajectory looks like coming into this period enrollment was very robust at our hope is that we can quickly start picking up steam again and as soon as we get to handle on it will give an update on what the overall impact is gonna be should our enrollment timeline previous call that we had said end of year 22.
He is full enrollment will obviously need to restart enrollment and see how that goes with it we can stay on track or not my hope is that we can get up quickly and hopefully any impact if there isn't it back it's going to be.
Minimal, but it's just impossible to predict that.
Okay got it.
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Hey, good questions. Thanks, operator.
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Standby always standby for any further questions.
I'm showing no questions at this time I'd like to turn the conference back over to charging for his closing remarks.
[noise] on behalf of the entire leadership team I like to thank you all very much for joining us. This afternoon, we look forward to updating you into page on the ongoing progress.
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This does concludes today's conference call you may now disconnect. Thank you and have a great day.
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