Q2 2021 Clovis Oncology Inc Earnings Call
Yeah.
Okay.
Ladies and gentlemen, thank you for standing by and welcome to the Clovis Oncology Q2, 2021operating results webcast conference call. At this time, all participants lines are in a listen only mode.
After the speaker's presentation, there will be a question and answer session to ask a question. During the session you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded if you require any further assistance. Please press star zero I would now like to hand the conference.
Over to your Speaker and assessment Vice President of Investor Relations. Thank you. Please go ahead.
Hey can you tell us hey, good morning, everyone welcome to the Clovis oncology second quarter 2021 conference call.
Thanks for joining us.
You've likely seen this morning's press release, if not it's available on our website.
Dot com.
As a reminder, this conference call is being recorded and webcast from.
Maybe asked US why then I would say during the call and will be available on our cash for the next several weeks today's agenda includes the following Patrick the happy hour President and CEO will discuss the highlights of today's corporate update and then Dr. Thomas Harding, Our Chief Scientific Officer, who will present, an update on it as a feature to a fixed and targeted radionuclide therapy development.
Programs.
Tucker Lindsey Rolfe, our Chief Medical Officer will discuss the anticipated upcoming clinical milestones for for broadband I think Peter to Asics, then Daniel <unk>, Our Chief Financial Officer will cover the quarter's results in greater detail Patrick will make a few brief remarks, Oh, sorry, a few breaks out from.
From here on corporate strategy and make a few closing remarks, and then we'll open the call for Q&A during which time, Pat and Tom and myself will be available for questions.
Before we begin please note that during today's conference on May make forward looking statements within the meaning of the federal securities laws, including statements concerning our financial outlook and expected business.
All these statements are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward looking statements.
Our actual results could differ materially due to a number of factors, including the extent on duration of the effects of the COVID-19, pandemic and the timing and extent of recovery from it.
Please refer to our recent filings with the SEC for a full review of the risks and uncertainties associated with their business for.
When looking statements speak only as of the date on which they are made and Clovis undertakes no obligation to update or revise any forward looking statements. Additionally, please note that we'll be discussing cash burn a non-GAAP financial measure during todays conference call.
Required disclosures related to this or in today's news release, which can be found on our website now I'll turn the call over to Patrick Mahaffy.
Thanks, Ana good morning, everybody. Thanks for joining I appreciate you taking the time.
Look while these are clearly complicated times.
Im encouraged that based on the data available to US we have maintained our U S market share for breakfast and we have achieved meaningful growth in sales in Europe in the second line maintenance ovarian cancer setting.
Sales in Q2, 2021 for $36.8 million lower than both Q2.2020 in Q1 'twenty 'twenty 1.
This decline is primarily result for the ongoing effects of the pandemic on oncology treatment on practice and in particular in ovarian cancer.
While we fully expect this to reverse when the pandemic finally abate and as reported by other oncology focused company. It has clearly had an impact on new patient diagnoses in new patient starts.
We anticipate that 1 patient visits begin to rise as diagnoses increase and the urgent need to more actively manage this often fatal disease gross.
The maintenance treatment of ovarian cancer patients will increase including the use of <unk> for women with advanced disease.
We are encouraged however that we successfully maintained enrollment in our clinical studies and accordingly, we've made significant progress on our clinical trial program for Brexit.
Importantly, we are ever closer to net 1 but 3 phase III readouts for <unk> in the next 6 to 18 months, we anticipate things re readouts from our Athena monotherapy Triton free and a senior combination studies of Rebecca all of which will occur in 2022.
As a reminder, Athena is evaluating your bracket in the first line ovarian cancer maintenance treatment setting.
First as monotherapy versus placebo and later on a separate analysis in combination with opdivo versus rubric of monotherapy.
Crichton free is evaluating Rebecca versus physicians choice for chemotherapy or second line androgen deprivation therapy.
Patients with metastatic castration resistant prostate cancer with BRCA and ATM mutations.
These offer the potential to address larger patient populations and earlier lines of therapy for both ovarian and prostate cancer, which.
Which we anticipate will drive growth and Rebecca sales on both the U S and Europe for.
Lindsay will shortly provide an update on these clinical programs.
In addition, we have great enthusiasm for the early stage pipeline opportunity, but targeted Radiotherapeutic development offers and we continue to advance our targeted radionuclide therapy pipeline as we seek to establish ourselves as a leader in this emerging field of oncology development.
F. P..22, 86 is the first peptide targeted radionuclide therapeutics targeting if a P to enter clinical development in the next 18 months will be potentially transformational for this program.
Tom and Lindsay will speak in more detail on 2 developments about this program.
And lastly, I'm pleased to announce that during the quarter, we raised $72.5 million in net proceeds through our at the market or ATM equity offering program.
As of June 30th we have $232 million on cash and cash equivalents and $48.1 million on available funding under the Athena financing.
And Dan will speak to this in greater detail shortly.
Before I turn the call over to Tom I'd like to take a moment to welcome Dr. A real need for cement off as the newest addition to our board of directors.
Rooney is currently Chief Medical Officer, Demeter cell and has served in senior leadership roles at Pfizer OSI kerogen from there.
We believe for experience and expertise in oncology clinical development and research will be invaluable to us as we advance our development pipeline.
We're very pleased to welcome her to the Clovis Board.
Now I'll turn the call over to Dr. Thomas Harding, our Chief Scientific officer to discuss the F 22, 86, and targeted radionuclide therapeutic development programs Tom.
Thanks Pat.
Hello, It's a pleasure to speak with you today.
As we've discussed we are seeking to establish ourselves as the leader in the talk to radiotherapy class share.
He is a developer.
22, 86, a lead talk to you for radio therapeutic compound license as part of our ongoing collaboration with <unk> Pharmaceuticals.
S. A P..2 to 8.6 is the first peptide targeted radiotherapy candidate for P. T. R. T targeting fibroblast activation protein also known as S and clinical development.
And as Pat mentioned, the next 18 months will be transformative for this program.
I think he is highly expressed on cancer associated fibroblasts will cash which represent 1 of the most abundant cell components from tumors and I found in the majority of cancer types.
Potentially a suitable target across a wide range of tumors, including breast lung colorectal and pancreatic carcinomas.
Cash play a critical role in tumor initiation progression metastasis and therapeutic resistance. For example, recent studies have demonstrated the S. A peaks for some cash.
Potent immunosuppressive activity that can promote tumor progression and confer resistance to immune based therapies, such as PD, 1 PDL 1 blockade.
In certain tumor types, such as sarcoma music dilemma.
May also be expressed on the tumor cells. In addition to the cash.
S. A P..22 86 consists of 2 functional elements first attempting peptides defined peaks foreseen capsule tumor cells from.
Second a site that can be attached used to attached radioactive isotopes.
Depending on the specific radioactive isotope attached F..22, 86 can be used for patient imaging and selection for therapeutic use.
In our phase 1.2 loom yesterday.
2026 is attached the honestly took gallium 68 to.
To allow positron emission tomography for pet imaging and selection of patients for inclusion in the study.
So the therapeutic agent F..22, 86 is attached to the isotope lutetium 177 in the midst of a beta particle ionizing radiation the causes DNA damage and cell death.
The phase 1 portion of Illumina study, which is now enrolling patients will evaluate the safety of U S. A P <unk> investigational therapeutic agents.
Densify the recommended phase 2 dose and schedule of lutetium on 77 labeled F 2026.
F 'twenty 'twenty 6 leap with gallium 68 will be used as an investigational imaging agent to identify patients with <unk> positive tumors appropriate for treatment in Louisiana.
Once the phase 2 dose is determined phase 2 expansion cohorts planned in multiple tumor types.
In addition to our own program a separate investigator sponsored imaging study with F..22, 86 is underway at UCSF to evaluate F. A P expression in multiple tumor types and is currently enrolling patients.
Results from this study along with the preclinical data we are generating are expected to help inform selection of tumor types for a phase 2 expansion cohorts.
As evidence of our commitment to this emerging field, we've created educational materials to enhance our investors' understanding of targeted radiotherapy.
The first of these materials are microsite and introductory video to provide more information about targeted radiotherapy.
22, 86 and closed just targeted radionuclide development program children.
To learn more please visit targeted radiotherapy dot com.
Lastly, we are collaborating with <unk> pharmaceuticals on a discovery program directed at 3 additional targets for tucked it radionuclide therapeutic development to which we have global rights.
We made potentially file an <unk> for a second candidate for this program in the second half of 2022.
And with that I'll now turn the call over to Lindsey Rolfe for clinical update.
Thanks, Tom and good morning, everyone. That's behavior day to discuss the key clinical milestones expected for 2026 in 2022.
Through <unk>, we are expecting topline clinical data from the Athena monotherapy arm in the first quarter of 2022 based on event based projects.
Data from the combination arm with Opdivo.
Defense for US is Rebecca monotherapy are expected in the second half of 2020 based on our principal to find assumption.
As a reminder, Athena is our phase III 1000 patient study in frontline newly diagnosed.
Net income.
With Athena, we believe we are uniquely positioned to evaluate Nebraska in terms as 2 independent outcomes.
Monotherapy versus placebo in the first line maintenance setting as well as well as potential on stage of the combination of Nebraska, plus Opdivo as a group record on in the same price lines maintenance.
Sure.
We believe this study on this as an opportunity to truly differentiate <unk> in.
In the frontline maintenance setting.
Once top line monotherapy results for favorable we plan to file on S. NDA shortly thereafter.
Continuing with meet them on stands for robust top line data from the Triton free trial are expected in the second quarter of 2022.
<unk> is a phase III study evaluating Rebecca versus physicians choice for chemotherapy or second line androgen deprivation.
And patients with Mci L. P C with BRCA or ATM mutation.
This trend is expected to serve as the complementary studies for Libre has current appraisals in the prostate indication as well as the potential.
Expansion.
And we plan to file an S. NDA shortly on results are available.
These 3 anticipated data readout athene on a therapy as senior combination.
<unk>.
Provide the potential to reach larger patient population in earlier lines of therapy for both.
A variant on prostate cancer for which Sue Brown cases currently approved in late line indications.
The timing for each day to read out is contingent upon the occurrence of the protocol specified progression free survival events.
These studies have been a non dedicated asset on the part of volume.
Traffic teams and I'm very grateful to the many colleagues and investigated his dedicated assets have shifted these phase III trials to maturity.
Lastly for Becker the Lodestar study is on phase III punching.
The study evaluated <unk> in patients with your current pretty tuman associated with the deleterious homologous recombination repair or HR.
Gene mutation that includes bradco with certain other gene.
Based on initial results from young guns study, we see encouraging evidence of activity in the subgroup of patients with the Biallelic gene mutation for double hit and Bracco other HR on targeted genes.
Importantly for BRCA mutated breast.
On kinetic and certain other changes the majority of Chinas do have biallelic loss.
Based on these early data we are evaluating the potential development timeline.
National for GDP as well as determining diagnostic strategy.
An update on our next quarterly call.
Tom has provided a brief overview of the ongoing phase 1 linear study of ethanol piece so interesting.
And I'll take a moment to highlight the efforts underway to identify the tumor types for our planned phase II expansion cohorts, which we expect to initiate in 2022 as well as other anticipated milestones.
The identification of the expansion cohort is of considerable focus for us.
At the high levels of MVP expression observed in multiple tumor types make it challenging to limit those expansion cohorts to define chamber types coming from.
We look forward to updating you on actually is for.
Peter.
Got it.
In addition to initiating phase 2 expansion cohorts. During 2019, we anticipate several key milestones for the program, including the first presentation of Phase 1 day from Indiana to medical meeting the launch of our combination study program to explore S&P 'twenty 'twenty.
In combination with other oncology compounds.
Given the enrollment P expecting paths in mediating immuno suppression exploring the combination with PD, 1 PDL 1 blockade as a priority.
And lastly on potential R&D filing of F. 'twenty 'twenty 6 links to NSA Pete targeted for Mr. P T Aussie.
And with that I'll turn the call over to Dan to discuss second quarter financial results.
Thanks, Lindsay and Hello, everyone. We reported net product revenues for <unk> of $36.8 million for Q2, 2021 which included U S. Net product revenues of $27.7 million and ex U S. Net product revenues of $9.1 million set.
Second quarter 2021, net revenues, representing an 8% decrease compared to Q2.2020 in which we reported net revenues of $39.9 million.
Including net product revenues in the U S of $36.7 million on ex U S for $3.2 million.
Just on the data available to US we continue to maintain U S market share during the quarter. Despite a decrease in sequential revenues by contrast, our ex U S business increased sequentially from Q1 to Q2, and we are encouraged by our progress there.
What was reported net product revenue for a breaker $74.9 million for the 6 months ended June 30, 2021 which included U S. Net product revenue of $59.4 million on ex U S product revenue of $15.5 million compared to net product revenue for the same period in 2020 of $82.5 million.
Which included U S net product revenue of $76 million in ex U S. Net product revenue of $6.5 million.
Gross to net adjustments totaled 28, 6% globally in Q2.2021 compared to 25, 6% in Q1, 2021increase in U S. Ex U S revenues and public health service discounts on the U S were the main drivers.
This metric fluctuates quarter to quarter on its difficult to estimate our future revenues, but the high 20% level seems likely depending on the revenue on distribution mix from U S in Europe as per.
Previously discussed as European revenues increase in before from to the U S. Global G. T N will increase correspondingly.
Research and development expenses totaled $45.8 million for Q2.2021.
On 35 per cent compared to $69.9 million for the comparable period in 2020.
Primarily due to lower spending on ROE bracket clinical trials for you.
We expect research and development expenses to be lower than the full year 2021 compared to full year 2020.
Selling general and administrative expenses totaled $32.9 million for Q2, 2021 down 21 per cent compared to $41.9 million for the comparable period on too.
101 for.
For savings due to the COVID-19 situation globally, and overall cost reduction efforts for.
We expect SG&A expenses to decrease in 2020, 1 compared to 2020.
We reported a net loss for Q2 of $66.4 million for 61 per share compared to a net loss for the second quarter of 2020 of $92.2 million or $1.15 per share.
Turning now to a discussion of cash as of June 30, we had $232 million in cash on cash equivalents during the quarter, we raised $72.5 million from net proceeds through our at the market equity offering program on.
Also as of June 30, we had approximately $126.9 million on the sixth Street partners LLC, Athena clinical trial financing and had up to $48.1 million available to draw under the agreement to fund the expenses of these Athena trial.
We expect this $48.1 million should be mostly drawn down between Q3.2021 in Q4.2022.
Net cash used in operating activities was $46.8 million for Q2, 2021 down 22% from $59.9 million reported in Q2.2020.
Cash burn in Q2, 2021 was $33.4 million down 33% from $50.1 million in Q2.2020.
We have reduced both our R&D and SG&A expenses considerably compared to prior years. Most recently, we have reduced our R&D and SG&A expense by $33.1 million or 30% and reduced net cash used in operating activities by 22% compared to Q2.2020.
As you can see we have aggressively reduced expenses and cash burn over the last year and we'll continue our strong focus on this moving forward I'd.
I'd like to take a moment to discuss the absence of long term cash guidance on today's news release, our long term revenue projection ranges have been continually analyze on adjusted during the pandemic, but it has become increasingly difficult to anticipate or predict the ongoing and severe effect of COVID-19, especially with the returning and uncertainty caused by the doctor Varian and its associated impacts.
The upstream patient visits cancer diagnoses and debulk from surgeries that affect uptake for BRCA and the second line ovarian cancer maintenance setting have not recovered to pre pandemic levels. This makes revenue range assumptions less predictable.
At this time as it will be disclosed in our form 10-Q for the period ending June 30 based on current revenue estimates, we have sufficient cash and available liquidity under our being a financing agreement to fund our current operating plan for at least the next 12 months. However, we cannot predict revenues with sufficient accuracy to provide cash guidance beyond that.
We made additional clarity into the abatement of the pandemic reported this can be done.
As noted earlier, we maintain our focus on cost controls on balance sheet management to mitigate the cash impact of for breakfast unpredictable revenue situation in this challenging environment. We believe that there is adequate flexibility within our operating plan to adjust variation variations in our expected revenue, Rebecca revenues and the availability and timing of potential.
Sources of financings.
I'll turn the call back to Pat.
Thanks, Dan.
Obviously, I Echo Dan's statement about this being a challenging time.
But also note that programs we implemented over the last several years are setting the stage for I believe will be a strong and exciting 2022 and beyond.
Let me review, our key strategies and our focus on creating value for shareholders over the next few years.
First we seek to drive Rebecca revenue growth.
We continue to pursue organic growth over bracket in the U S and European our current indications as the effect of the COVID-19 pandemic resolves over time.
However, we believe the more significant opportunity to drive revenue growth for Rebecca will come from the 3 phase III studies that will read out over the next 6 to 18 months.
Each readout if successful offers the opportunity to expand for breakfast labels in the U S and Europe to a larger and earlier line patient population.
Second we seek to become a leader in targeted radionuclide therapy.
The lumi are phase 1.2 clinical study of F..22, 86, the first part the first peptide targeted radionuclide therapy targeting <unk> in clinical development.
Now open for enrollment.
We intend to aggressively aggressively move F 22, 86 in the phase 2 cohorts of linear.
And if you need additional monotherapy and combination studies and begin clinical candidate of an additional radio therapeutic candidate in 2022 as part of that commitment to lead in this emerging field of oncology development.
And third we seek to achieve long term financial stability by transitioning our R&D focus from large phase III for breakfast studies to our earlier stage targeted radionuclide development programs.
Maximizing Rebecca as revenue potential through label expansion as well as a return to growth in our current indication when the stay on pandemic finally and we.
We will maintain our ongoing cost containment efforts, which have resulted in significantly lower total SG&A and R&D spending.
These strategies formed the foundation of our focus to create value for shareholders.
Corporate presentation, describing these goals will be available on the investors section of our website after today's call.
I am very proud of our team of Clovis, whose hard work dedication and commitment to improving the lives of cancer patients.
This old toward our goals.
We expect the next 6 to 18 months to be eventful with the potential to transform Clovis and provide additional value creation.
And with that we will be happy to answer any questions you may have.
Thank you.
As a reminder to ask a question you would need to press star 1 on your telephone to withdraw your question press the pound key please stand by while we compile the Q&A roster.
Okay.
Your first question comes from the line of Cory CASM mob with J P. Morgan.
Your line is known for.
Hi, This is gavin on for Cory Thanks for taking our questions. Just a quick 1 on 2286 development program for linear can you just talk about the.
Rate of patient accrual and when we should expect thanks for.
Vito.
Yeah.
Lindsay.
So.
As you would expect for the first demand study is a dose escalation study.
And with each total being.
<unk> enrolled sequentially with a safety follow up period after the last patient in these total team being enrolled.
To ensure that it is safe enough for me.
Moving to the next dosing cohort.
And we'll expect to see safety data coming right from the beginning on.
But as I said first in man study.
Let's take this.
A few couple of to get to the dosing levels.
While we may potentially see activity. So safety first then entity coming coming true.
Okay, great. Thank you.
Your next question comes from the line up to Zane Amas with Bank of America.
Hi, Good morning can you hear me.
Yes.
Great how are you good.
From you.
Can you come from color about the dynamics.
You've talked about having made changes to your marketing.
As you know.
Very very early on in Covid and ethylene Unfortunately continued lift through the effects of it.
Just wondering the changes that you made how do you think that they have played out I mean do you think that you know.
If things never go back to completely non amount, but improved from here that the changes you've made what position.
On your team to market effectively and then I have a follow up.
I do.
Obviously excess you'll hear this from everybody.
Improved somewhat but it's still somewhat limited and so.
On an era, where were access is very limited.
The sales reps are limited to zoom calls that they can get them. Other means of electronic communication. It became evident that augmenting those activities with a significant digital presence.
Was not only good practice because of Covid, but directionally is where are our physician population.
On wants to gain information on their own time at home in their office.
And and I think and others have suggested they will pursue a similar approach we pursue it as well to the extent we can in Europe.
And I think that it actually.
Was timely as.
As we noted at the time. It did result in a cost savings and you'll leave around $10 million. That's we're grateful for that.
The metrics we have we're on.
The program has been rolled out in a targeted way.
And the metrics we have.
In in.
In the targeted population demonstrate.
<unk>.
Improvements in market share in most cases.
And we were learning ever more about the number of hits, whether it's in person.
Our digital.
That are that are necessary to drive a script and adoption. So we're learning a lot.
We continue to be affected as everybody is by Covid, but I I don't doubt. This is a better 20, <unk> century version of oncology promotion and marketing.
Okay.
You know assuming that BP and our results are positive.
With your efforts to expand into earlier lines of therapy required to make any changes to these efforts or would it be.
Just you know.
Add on.
Do you need additional resources.
I mean there'll be some marketing spend.
To reflect the.
The new data and the launch almost relaunch for BRCA into this indication.
But I.
I don't anticipate.
Any meaningful if any.
And the Oregon on organizational structure or in our approach.
2.
Using this hybrid model. So I don't I don't I think the effects for dollar effects will be largely.
You can see invisible at a minimum limited in terms of our SG&A spend.
Okay, great. Thanks, Scott.
<unk>.
Your next question comes from the line of Paul Choi with Goldman Sachs.
Hi, everyone. Good morning, a few from us.
Maybe starting with prostate could you maybe just sort of comment on.
Our field, our office physician office dynamics, and if you are seeing perhaps access and greater access our utilization and 1 settings, such as urology vs versus the medical oncologist and then I had a follow up question.
We have a limited effort directed.
Directed that urologists, thus far.
Just because.
We're all aware that until the Triton free day to get into the label that we do have a labeled disadvantage.
So I don't have an easy answer.
I would say, though debt.
The access issues are regional.
And tend to be quite a bit more significant in the northeast than for instance in parts of the south but we wonder if that will change again in relationship to.
Covid and the Delta variant driving.
So moving pieces now.
In the south and so I would say Paul that.
It is variable, it's getting a little bit better to the number of in person calls made.
In Q2 versus Q1.
For a meaningful step forward, but still not where.
Where we want to be and again I'll say it again.
I think that Covid.
Not only causes effects, but accelerates ongoing trends and I think the ongoing trend of more limited access, particularly in academic institutions will continue even as Covid finally goes away.
Okay, maybe just to follow up on that path given that this is largely.
Mostly COVID-19 vaccine.
Vaccinated population.
In your mind is it will be inflection largely be driven by by the Triton for a label change pending pending that update in your view over time or is it still fell over the near to intermediate term largely pandemic driven.
Paul I don't I don't know that I understood that question and I apologize did you mind, asking but again Oh, yeah sure I guess, just you know what what primary factor do you see as the label as the driving future inflection or uptake in the setting is it more resolution of Covid or.
Our future label changes to your earlier comment we.
We need Triton tree.
We've got it Im sorry, we need we need we need to move into an early line.
And earlier lines of therapy that has us on a on.
Equivalent ground.
With elaborate.
Okay, great thanks for that debt.
And then 1 just quick 1 on 2286 out which is just with regard to the to the supply chain.
Can you maybe just comment just given the I guess relative scarcity of lutetium, just where you are with regard to for supplying sourcing that and your manufacturing process on that and just how you think about sourcing about for your for your clinical development. Thank you very much.
Yeah, we haven't named our supplier, but it's 1 of the larger and we don't have a long term supply agreement like a commercial supply agreement, we anticipate that will develop over the next couple of years, but we do have a clinical supply agreement with them and we don't have any doubt that they will be able to meet.
Our trial needs and potentially serve as our commercial supplier as we get closer to a potential hopefully accelerated approval in the coming several years.
I'll also note that Youre right.
That supply.
Both lutetium enact opinion for that matter.
Had been historically limited, but not only our current manufacturers of lutetium expanding their capacity new suppliers are are emerging because it is evidently an opportunity.
As the field.
Demonstrates progress and success and there's nothing I know that suggests we have any risk of a supply issue with boutiques from supply.
Okay. Okay. Thank you Pat I'll hop back in thank you.
Thanks, Paul.
Your next question comes from the line of Andrew Burns with SBB Leerink.
Hi, Thanks.
I just wanted to understand the comments.
The Lone Star trial and the.
The strategies you guys are planning it sounded from the.
Our prepared comments that you found the commutation biomarker that could lead to a tumor agnostic label and I wasn't really sure. What you said about breast ovarian and prostate as I thought those time for those tumors have been excluded from the trial. So can you clarify that and then also is it correct that the submitted.
Tumor types need to be exclusive of the tumor types that the class is already approved or.
Your drug.
I may have missed it but what did you say is the status of the debt instrument, that's too low expire this year.
Lindsay will enter Lindsay and timelines for the.
The Ah <unk>.
The question's on Lone Star.
Just briefly.
We.
The status of.
The debt that is due in September is it fully within our our cash planning is paying off the roughly $64 million on cash.
For the owners of the September 'twenty one's in September so that's.
That remains as plane that had been part of our cash.
Use planning.
For the last well for.
Several years.
Lodestar Lindsey do you want to start or for Tom do you want to talk about <unk> mutations are no go ahead Wendy.
Okay. Thanks for the questions Andy.
You're right when it comes to ovarian and prostate cancer patients.
Brad can you take it she was on <unk> and stuff.
They are included if they have mutations industry on the genes that we're looking at.
With you on seeking Pam.
And the comment about the subgroup with the binding of mutations that are time, Inc.
<unk> on the other 3 genes.
Thompson.
Tom do you want to elaborate a little bit about the double hit phenomenon.
Yeah sure Hello, Andy.
What we have observed and what we've observed in our preclinical and clinical studies to date.
It's a it's not sufficient just to have 1 BR CA.
On a deleterious mutation in the 5 genes are examining.
What we observed is that to be have efficacy you need hits in both copies of it's present on the cancer cell.
For ovarian breast pancreatic.
A very high rate.
However, if you look at other tumor types such as lung colorectal.
Frequency of this double hit that gives you the the a.
Efficacy of BRCA is less.
So we see this kind of difference in the frequency of this double hit or Biallelic loss, depending on the tumor type.
And because of that we're looking at this with foundation medicine.
We try and look out biallelic losses, as a potential companion diagnostic download.
Okay, and just just to clarify it for.
Patient has.
Take for them, but has another mutation.
Class since Youre looking at are they concluded or is breaker excluded from from the candidate pool.
The rules are always on a.
A little uncertain.
But by focusing on Biallelic mutations, which is a specific subset.
We optimistically believe.
This would include.
On.
This this could be a true pan tumor indication, even including in tumor types, where for a different biomarker.
For the classes already approved but that has to be worked out with FDA.
Okay, alright, thanks, a lot I appreciate all the color.
Again to ask a question. Please press Star then the number 1 on your telephone keypad to withdraw your question press the pound key.
Your next question comes from the line of Joe Catanzaro with Piper Sandler.
Hey, guys. Thanks, so much for taking my question, maybe 2 for me the first.
Is the delay in the monotherapy versus placebo arm of the Athena trial due to slower than expected event accrual it sounds like Thats, the case and you've always guided towards the combination coming 1 year. Later is there any risk that the combination of top line readout gets delayed into 2023, and how did the potential shift in top line readout.
Impact the timing of TPB.
Debt repayment and when that starts.
Okay.
Danville linked to the TPG question in a moment, but.
Lindsay, perhaps you could answer the kind of the clinical result timing questions Sean.
Thanks for the question Jim.
<unk>.
Estimation for readout for monotherapy as you suggested Inc is guided by.
On the current event rate.
And so it has been pushed out a little bit.
Because the events upcoming most loans.
We anticipated when we designed the trial.
For the monotherapy.
We expect that for the combination therapy, we expect that to read out later on.
And right now we're still using on.
Our principal defined assumptions.
On 2 to predict when that reads out.
We get.
Mirror to maturity for.
For the combination on.
We will be able to make a more precise estimate.
When the readout will occur but at this stage.
It's possible that it could go into 2023 on it you said.
Possibly.
And then.
At the end of 2022.
When we when we get nearer the time, we'll be able to do.
Not much more precisely.
And.
The net TPG pumps.
Hi, Joe This is Dan it doesn't have any impact on the TPG agreement.
The timing of that is already set so.
Indicated in my comments, we'll draw down the remainder of it mostly between Q3 and Q4 of next year and Thats on the payments start under any scenario.
Okay. Thanks Thats helpful on them.
As a follow up I don't think I heard was sitting had mentioned anywhere are there still expectations to present data from the Nemo combo endometrial cohort later this year and that the full approval of <unk> in this setting impact how you think about the longer opportunity. Thanks.
Yeah, well, we may present later this year.
On the <unk>.
Data from <unk>.
An additional cohort on.
Asleep.
On any any.
Commercial thoughts about sitting there and further clinical thoughts about.
We sit in a are currently under review and we'll await data from cohorts that are still enrolling to inform that decision.
Okay got it thanks for taking my questions you bet.
Yeah.
At this time there are no further questions I.
I would like to turn the call back over to Anna Sussman VP.
On the Investor Relations.
Thank you Bill.
We thank you all for your interest in Clovis oncology today do you have.
Any follow up questions. Please contact me at 3 O 365, 5 O 2.2 or bring on at 3 O 365, I heard from training to.
The call can be accessed via replay.
At our website beginning in about an hour and will be available for 30 days. We appreciate your interest and time, Inc. Thank you and have a good day.
Ladies and gentlemen that does conclude today's conference. We thank you for participating you may now disconnect.
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