Clovis Oncology, Inc. (CLVS) CEO Patrick Mahaffy on Q2 2021 Results - Earnings Call Transcript
Clovis Oncology, Inc. (CLVS) Q2 2021 Earnings Conference Call August 4, 2021 8:30 AM ET
Company Participants
Anna Sussman - IR
Patrick Mahaffy - CEO
Thomas Harding - Chief Scientific Officer
Lindsey Rolfe - Chief Medical Officer
Dan Muehl - CFO
Conference Call Participants
Gavin Scott - JPMorgan
Tazeen Ahmad - Bank of America
Paul Choi - Goldman Sachs
Andrew Berens - SVB Leerink
Joe Catanzaro - Piper Sandler
Operator
Ladies and gentlemen, thank you for standing by, and welcome to the Clovis Oncology Q2 2021 Operating Results Webcast Conference call. [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions]
I would now like to hand the conference over to your speaker, Anna Sussman, Vice President of Investor Relations. Thank you. Please go ahead.
Anna Sussman
Thank you, Bella. 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, and if not, it's available on our website at clovisoncology.com. As a reminder, this conference call is being recorded and webcast. Remarks may be accessed live on our website during the call and will be available on our archive for the next several weeks.
Today's agenda includes the following, Patrick Mahaffy, our President and CEO, will discuss the highlights of today's corporate update; and then Dr. Thomas Harding, our Chief Scientific Officer, will present an update on our FAP-2286 and targeted radionuclide therapy development programs; Dr. Lindsey Rolfe, our Chief Medical Officer, will discuss the anticipated upcoming clinical milestones for Rubraca and F2286; then Dan Muehl, our Chief Financial Officer, will cover this quarter's results in greater detail. Patrick will make a few brief remarks -- sorry, a few brief -- a brief review of corporate strategy and make a few closing remarks. And then we'll open the call for Q&A, during which John, Pat and Tom and Linde will be available for questions.
Before we begin, please note that during today's conference call, we may make forward-looking statements within the meaning of the federal securities laws, including statements concerning our financial outlook and expected business plans. 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 and duration of the effects for the COVID-19 pandemic and the timing and extensive recovery from it. Please refer to our recent filings with the SEC for a full review of the risks and uncertainties associated with our business. Forward-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 today's conference call. Required disclosures related to this are in today's news release, which can be found on our website.
Now I'll turn the call over to Patrick Mahaffy.
Patrick Mahaffy
Thanks, Anna. Good morning, everybody. Thanks for joining. Appreciate you taking the time. Look, while these are clearly complicated times, I'm encouraged that based on the data available to us, we have maintained our U.S. market share for Rubraca, and we have achieved meaningful growth in sales in Europe in the second-line maintenance ovarian cancer setting.
Sales in Q2 2021 were $36.8 million, lower than both Q2 2020 and Q1 2021. This decline is primarily a result of the ongoing effects of the pandemic on oncology treatment in practice and in particular, in ovarian cancer. While we fully expect this to reverse when the pandemic finally abates and as reported by other oncology-focused companies, it has clearly had an impact on new patient diagnoses and new patient starts. We anticipate that when patient visits begin to rise, as diagnoses increase and the urgent need to more actively manage this often fatal disease growth, the maintenance treatment of ovarian cancer patients will increase, including the use of Rubraca for women with advanced disease.
We are encouraged, however, that we've successfully maintained enrollment in our clinical studies. And accordingly, we've made significant progress in our clinical trial program for Rubraca. Importantly, we are ever closer to not 1 but 3 Phase 3 readouts for Rubraca in the next 6 to 18 months. We anticipate Phase 3 readouts from our ATHENA monotherapy, TRITON3 and ATHENA combination studies of Rubraca, all of which will occur in 2022. As a reminder, ATHENA is evaluating Rubraca in the first-line ovarian cancer maintenance treatment setting, first is monotherapy versus placebo and later in a separate analysis in combination with Opdivo versus Rubraca monotherapy. TRITON3 is evaluating Rubraca versus physician's choice of chemotherapy or second-line androgen deprivation therapy in patients with metastatic canceration resistant prostate cancer with BRCA and ATM mutations.
These offer the potential to address larger patient populations in earlier lines of therapy for both ovarian and prostate cancer, which we anticipate will drive growth in Rubraca sales in both the U.S. and Europe. Lindsey will shortly provide an update on these clinical programs.
In addition, we have great enthusiasm for the early-stage pipeline opportunity that 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. FAP-2286 is the first peptide-targeted radionuclide therapeutic targeting FAP to enter clinical development, and the next 18 months will be potentially transformational for this program. Tom and Lindsey will speak in more detail into 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 had $230.2 million in cash and cash equivalents and $48.1 million in 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. Ronit Simantov as the newest addition to our Board of Directors. Ronit is currently Chief Medical Officer at Gamida Cell and has served in senior leadership roles at Pfizer, OSI, CuraGen and Bayer. We believe her experience and expertise in oncology clinical development and research will be invaluable to us as we advance our development pipeline. We are 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 FAP-2286 and targeted radionuclide therapeutic development programs. Tom?
Thomas Harding
Thanks, Pat. Hello. It's a pleasure to speak with you today. As we've discussed, we are seeking to establish ourselves as a leader in the targeted radiotherapy class. Firstly is the developer of FAP-2286, our lead targeted radiotherapeutic compound licensed as part of our ongoing collaboration with 3B Pharmaceuticals. FAP-2286 is the first peptide-targeted radiotherapy candidate, or PTRT, targeting fibroblast activation protein, also known as FAP in clinical development. And as Pat mentioned, the next 18 months will be transformative for this program. FAP is highly expressed on cancer-associated fibroblasts or CAFs which represent one of the most abundant cell components in tumors and are found in the majority of cancer forms, making it potentially a suitable target across a wider range of tumors, including breast, lung, colorectal and pancreatic class numbers.
CAFs play a critical role in tumor initiation, progression, metastasis and therapeutic resistance. For example, recent studies have demonstrated that FAP expressing CAFs exit a potent immunosuppressive activity that can promote tumor progression and confer resistance to immune-based therapies, such as PD-1 or PD-L1 blockade. In certain tumor types, such as sarcoma
And mesothelioma, FAP may also be expressed on the tumor cells in addition to the CAFs.
FAP-2286 consists of 2 functional elements. First, a targeting-peptide that binds to FAP expressing CAFs and tumor cells, and second, a site that can be attached used to attach radio isotopes. Depending on the specific radioactive isotope attached, FAP-2286 can be used for patient imaging and selection or therapeutic use. In our Phase 1/2 LuMIERE study, FAP-2286 has attached the isotope gallium-68 to allow positron emission tomography or PET imaging and selection of patients for inclusion in the study. For the therapeutic agent, FAP-2286 is attached to the isotope lutetium-177, an emitter beta particle ionizing radiation that causes DNA damage and cell death. The Phase 1 portion of the LuMIERE study, which is now enrolling patients, will evaluate the safety of the FAP targeting investigational therapeutic agent and identify the recommended Phase 2 dose in schedule of lutetium-177 labeled FAP-2286.
FAP-2286 label with gallium-68 will be used as an investigational imaging agent to identify patients with FAP positive tumors appropriate for treatment in LuMIERE. Once the Phase 2 dose is determined, Phase 2 expansion cohorts are planned in multiple tumor types. In addition to our own program, a separate investigator-sponsored imaging study with FAP-2286 is underway at UCSF, to evaluate FAP expression in multiple tumor types and it's currently enrolling patients. Results from this study, along with the pre-clinical data we are generating are expected to help inform selection tumor types for our Phase 2 expansion cohorts.
As evidence of our commitment to this emerging field, we have created educational materials to enhance our investors' understanding of targeted radiotherapy. The first of these materials are a microsite, an introductory video that provide more information about targeted radiotherapy, FAP-2286 and Clovis' targeted radionuclide development program. To learn more, please visit targetedradiotherapy.com.
Lastly, we are collaborating with 3B Pharmaceuticals on a discovery program directed at 3 additional targets for targeted radionuclide therapeutic development, to which we have global rights. We may potentially file an IND 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.
Lindsey Rolfe
Thanks, Tom, and good morning, everyone. I'm glad to be here with you today to discuss the key clinical milestones expected for Rubraca and FAP-2286 in 2022. Rubraca, we are expecting top-line clinical benefit from the ATHENA monotherapy arm in the first quarter of 2022 based on event-based projections. Data from the combination arm of Rubraca plus Opdivo versus Rubraca monotherapy are expected in the second half of 2022 based on our protocol-defined assumptions. As a reminder, ATHENA is a Phase 3 1,000 patient study in front-line newly diagnosed advanced ovarian cancer maintenance. With ATHENA, we believe we are uniquely positioned to evaluate Rubraca in terms of 2 independent outcomes. Monotherapy versus placebo in the first-line maintenance setting as well as a potential advantage of the combination of Rubraca plus Opdivo over Rubraca alone in the same first-line maintenance setting.
We believe this study offers an opportunity to truly differentiate Rubraca in the frontline maintenance setting. Once top-line monotherapy results are available, we plan to file an sNDA shortly thereafter. Continuing with the other milestones for Rubraca, top-line data from the TRITON3 trial are expected in the second quarter of 2022. TRITON3 is a Phase 3 study evaluating Rubraca versus physician's choice of chemotherapy or second-line antigen deprivation therapy in patients with mCRPC with BRCA or ATM mutations. This plan is expected to serve as the complementary studies for Rubraca's current approval in the prostate indication as well as a potential second line label expansion, as we plan to file an sNDA shortly after results are available.
These 3 anticipated data readouts, ATHENA monotherapy, ATHENA combination and TRITON3 provide the potential to reach larger patient population in earlier lines of therapy for both ovarian and prostate cancer, for which Rubraca is currently approved in later-line indication. The timing for each data readout is contingent upon the occurrence of the protocol specified production pre-survival events. These studies have been a long and dedicated effort on the part of our Rubraca team, and I'm very grateful to the many colleagues and investigators whose dedicated efforts are sheparding these Phase 2 trials to maturity.
Lastly, Rubraca, the LODESTAR study is our Phase 2 pan-tumor chemo study. The study evaluate Rubraca in patients with the solid tumors associated with the deleterious homologous recombination repair or HRR gene mutation that includes BRCA with certain other genes. Based on initial results from the ongoing study, we see encouraging evidence of activity in the subgroup of patients with a biallelic tumor mutation or double hit in BRCA or other HRR targeted genes. Importantly, the BRCA mutated breast, pancreatic and certain other genes, the majority of tumors do have biallelic lot. Based on these early data, we are evaluating the potential development time line and commercial opportunity as well as determining a diagnostic strategy, which we'll provide an update on our next quarterly call.
Tom has provided a brief overview of the ongoing Phase 1 LuMIERE study of FAP-2286, and I'll take a moment to highlight the efforts underway to identify the gene types for our planned Phase 2 expansion cohorts, which we expect to initiate in 2022 as well as other anticipated milestones. The identification of the expansion cohort is a considerable focus for us as the high levels of FAP expression observed in multiple tumor types, make it challenging to limit those expansion cohorts to the 5 tumor sites probably planned. We look forward to updating you on our choices for Phase 3 study in the coming quarters.
In addition to initiate LuMIERE Phase 2 expansion cohorts during 2022, we anticipate several key milestones for this program, including the first presentation of Phase 1b from LuMIERE as a medication, the launch of our combination study program to explore FAP-2286 in combination with other oncology compounds. Given the role of FAP expressing types in mediating immunosuppression, exploring the combination with PD-1, PDL-1 blockade is a priority. And lastly, a potential IND filing of FAP-2286 linked to an FAP targeted alpha emitter PTRT.
And with that, I'll turn the call over to Dan to discuss second quarter financial results.
Dan Muehl
Thanks, Lindsey, and hello, everyone. We reported net product revenues for Rubraca 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. Second quarter 2021 net revenues represent an 8% decrease compared to Q2 2020, in which we recorded net revenues of $39.9 million, including net product revenues in the U.S. of $36.7 million and ex-U.S. of $3.2 million.
Based on the data available to us, we continue to maintain U.S. market share during the quarter despite a decrease in sequential revenues. In contrast, our ex-U.S. business increased sequentially from Q1 to Q2, and we are encouraged by our progress there.
Clovis reported net product revenue for BRCA of $74.9 million for the 6 months ended June 30, 2021, which included U.S. net product revenue of $59.4 million and 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 and 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 2021, increasing U.S. rev -- ex-U.S. revenues and public health service discounts in the U.S. were the main drivers. This metric fluctuates quarter-to-quarter and it's difficult to estimate our future revenues, but the high 20% level seems likely, depending on the revenue and distribution mix of the U.S. and Europe. As previously discussed, as European revenues increased in proportion to the U.S. Global GPN will increase correspondingly.
Research and development expenses totaled $45.8 million for Q2 2021, down 35% compared to $69.9 million for the comparable period in 2020, primarily due to lower spending on Rubraca clinical trials. We expect research and development expenses to be lower in the full year 2021 compared to full year 2020.
Selling, general and administrative expenses totaled $32.9 million for Q2 2021, down 21% compared to $41.9 million for the comparable period into 2020, with savings due to the COVID-19 situation globally and overall cost reduction efforts. Further, we expect SG&A expenses to decrease in 2021 compared to 2020. We reported net loss for Q2 of $66.4 million or $0.61 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 the discussion of cash. As of June 30, we had $230.2 million in cash and cash equivalents. During the quarter, we raised $72.5 million in net proceeds to our ATHENA market equity offering program. Also, as of June 30, we had approximately $126.9 million under 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 the ATHENA trial. We expect this $48.1 million to be mostly drawn down between Q3 2021 and Q4 of 2022.
Net cash used in operating activities was $46.8 million for Q2 2021, down 22% from the $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 reduced 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 a strong focus on this moving forward.
I'd like to take a moment to discuss the absence of long-term cash guidance in today's news release. Our long-term revenue projection ranges have been continually analyzed and adjusted during the pandemic, but it's become increasingly difficult to anticipate or predict the ongoing and severe effect of COVID, especially with the return and uncertainty caused by the Delta Variant and its associated impacts. The upstream patient visits, cancer diagnoses and debulking surgeries that affect uptake of Rubraca in 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 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 ATHENA 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 need additional clarity into the abatement of the pandemic reports before this can be done.
As noted earlier, we maintain our focus on cost controls and balance sheet management to mitigate the cash impact of Rubraca's unpredictable revenue situation in this challenging environment, to believe that there is adequate flexibility within our operating plan, to adjust variations in our expected revenue, Rubraca revenues and the availability and timing of potential sources of financings.
I'll turn the call back to Pat.
Patrick Mahaffy
Thanks, Dan. Obviously, I echo Dan's statement about this being a challenging time. But also note, the 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 Rubraca revenue growth. We continue to pursue organic growth of Rubraca in the U.S. and Europe in our current indications as the effect of the COVID-19 pandemic results over time. However, we believe the more significant opportunity to drive revenue growth for Rubraca will come from the 3 Phase 3 studies of the readout over the next 6 to 18 months. Each readout, if successful, offers the opportunity to expand Rubraca's 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 linear Phase 1/2 clinical study of FAP-2286, the first peptide-targeted radionuclide therapy targeting FAP and clinical development, is now open for enrollment. We intend to aggressively move FAP-2286 in the Phase 2 cohorts of LuMIERE, to initiate additional monotherapy in combination studies and begin clinical candidate of an additional radiotherapeutic 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 3 Rubraca studies to our earlier-stage targeted radionuclide development programs, maximizing Rubraca's revenue potential through label expansion as well as a return to growth in our current indications when the pandemic finally end. We will maintain our ongoing cost containment efforts, which have resulted in significantly lower total SG&A and R&D spending. These strategies form the foundation of our focus to create value for shareholders. The corporate presentation describing these goals will be available on the Investors section of our website after today's call.
I'm very proud of our team at Clovis, whose hard work, dedication and commitment to improving the lives of cancer patients moves us all 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.
Question-and-Answer Session
Operator
[Operator Instructions] Your first question comes from the line of Cory Kasimov with JPMorgan.
Gavin Scott
This is Gavin on for Cory. Just a quick one on 2286 development program. For LuMIERE, can you just talk about the rate of patient accrual and when you should expect potential data?
Patrick Mahaffy
Lindsey?
Lindsey Rolfe
Sure. So it's -- as you'd expect for a first LuMIERE study, it's a dose escalation study with each cohort being enrolled sequentially with a safety follow-up period after the last patient each cohort has been enrolled to ensure that it's safe enough to move through to the next dosing cohort. We'll expect the safety data coming right from the beginning. But as I said, it's demand study, so it takes us a few cohorts to get to the dosing levels where we may potentially see activity. So safety first, then activity coming through later.
Operator
Your next question comes from the line of Tazeen Ahmad with Bank of America.
Tazeen Ahmad
Can you give us some color about the dynamics? You've talked about having made changes to your marketing efforts very, very early on in COVID. And as we've unfortunately continued to list through the effect of it, I am just wondering the changes that you made, how do you think that they have played out? I mean, do you think that if things never go back to completely normal but improve from here, that the changes you've made will position your team to still market effectively? And then I have a follow-up.
Patrick Mahaffy
I do. And obviously, access -- you'll hear this from everybody. Improved somewhat, but it's still somewhat limited. And so, in an era where access is very limited and 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 our physician population wants to gain information on their own time, at home, in their office. 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 we noted at the time, it did result in the cost savings annually of around $10 million.
That's -- we're grateful for that. The metrics we have where the program is being rolled out in a targeted way. And the metrics we have in the targeted population demonstrate improvements in market share in those cases and we're learning ever more about the number of hits, whether it's in person or digital, 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 don't doubt this is a better or 21st century version of oncology promotion and marketing.
Tazeen Ahmad
Okay. And assuming that the ATHENA 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 add on would you need additional resources?
Patrick Mahaffy
I mean, there'll be some marketing spend to reflect the new data and the launch, almost relaunch of Rubraca into this indication. But I don't anticipate any meaningful, if any, change in the organizational structure or in our approach to using this hybrid model. So I don't -- I think the effects -- the dollar effects will be largely, I was going to say, invisible, at a minimum, limited in terms of our SG&A spend.
Operator
Your next question comes from the line of Paul Choi with Goldman Sachs.
Paul Choi
A few from us. Maybe starting with prostate. Could you maybe just sort of comment on field or office -- physician office dynamics? And if you are seeing perhaps accessing -- greater access or utilization in one setting such as urology versus the medical oncologist? And then I have a follow-up question.
Patrick Mahaffy
We had a limited effort, directed urologists thus far just because you're all aware that until the TRITON3 data get into the label, that we do have a label disadvantage. So I don't have an easy answer. I would say, though, that the excess 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 many cases now in the South. And so I would say, Paul, that it is variable.
It's getting a little bit better. The number of in-person calls made in Q2 versus Q1 were a meaningful step forward, but still not where we want to be. And again, I'll say, 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.
Paul Choi
Okay. Maybe just to follow-up on then, Pat, given that this is largely or mostly COVID vaccinated population. In your mind, is the -- will the inflection largely be driven by the TRITON3 label change pending that update in your view over time? Or is it still over the intermediate term largely pandemic-driven?
Patrick Mahaffy
Paul, I don't know that I understood that question, and I apologize. Do you mind asking that again?
Paul Choi
Yes, sure. I guess just what primary factor do you see as the label -- as the driving future inflection or uptake in this setting? Is it more resolution of COVID or future label changes to your earlier comments?
Patrick Mahaffy
We need TRITON3. We need to move into an earlier line of therapy that has us on an equivalent ground with olaparib.
Paul Choi
Okay. Great. Then one -- just quick one on 2286, which is just with regard 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 supplying -- sourcing that and your manufacturing process on that? And just how do you think about sourcing that for your clinical development?
Patrick Mahaffy
Yes. We haven’t named our supplier, but it’s one 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’d also note that you’re right, that supply of both lutetium and actinium, for that matter, has been historically limited, but not only our current manufacturers of lutetium expanding their capacity, new suppliers 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 lutetium supply.
Operator
Your next question comes from the line of Andrew Berens with SVB Leerink.
Andrew Berens
Pat, I just wanted to understand the comments about the LODESTAR trial and the strategy you guys are planning. It sounded from the prepared comments that you found a co-mutation biomarker that could lead to a tumor-agnostic label. And I wasn't really sure what you said about breast, ovarian and prostate is. I thought those time -- 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? And then I may have missed it, but what did you say is the status of the debt instrument that's to expire this year?
Patrick Mahaffy
Lindsey will answer -- Lindsey and Tom will answer the the questions on LODESTAR. Just briefly, we -- the status of the debt that is due in September is that fully within our cash planning is paying off the roughly $64 million in cash to the owners of the September '21s in September. So that remains as planned. That has been a part of our cash use planning for the last -- well, for several years. LODESTAR, Lindsey, do you want to start or Tom, do you want to talk biallelic mutations or...
Thomas Harding
No, go ahead, Lindsey.
Lindsey Rolfe
Okay. So thanks for the questions, Andy. You're right. When it comes to ovarian and prostate cancer, patients with BRCA-mutated tumors aren't included in LODESTAR but they are included if they have mutations in the 3 other genes that we're looking at, BRCA, is you won't see the impact there. And the comment about the subgroup with the biallelic mutations, that applies equally well to BRCA1, 2 and the other 3 genes. Tom, do you want to elaborate a little bit about the double hit phenomenon?
Thomas Harding
Yes, sure. Andy, what we observed -- what we've observed in our preclinical and our clinical studies to-date is that, it's not sufficient just to have 1 BRCA or deleterious mutation in the 5 genes that are examining. What we observe is that, to we have efficacy, we need to sit both copies that's present in the cancer cell. And for ovarian, breast, pancreatic, that happened at a very high rate. However, if you look at other tumor types, such as lung, colorectal, the frequency of this double hit that gives you the efficacy of Rubraca is less. And 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 to actually try and work out biallelic glass as a potential companion diagnostic demo.
Andrew Berens
Okay. And just to clarify, if the patient has a BRCA mutation but has another mutation of the class that you're looking at, are they included or is BRCA excluded from the candidate pool?
Thomas Harding
The rules are always a little uncertain. But by focusing on biallelic mutations, which is a specific subset, we optimistically believe that this would include – this could be a true pan-tumor indication, even including in tumor types where for a different biomarker, a number of the classes already approved. But that is to be worked out with FDA.
Operator
[Operator Instructions] Your next question comes from the line of Joe Catanzaro with Piper Sandler.
Joe Catanzaro
Maybe two from 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 that's the case. And you've always guided towards the combination coming 1 year later. Is there any risk that the combination top line readout gets delayed into 2023? And how does the potential shift in top line readouts impact the timing of TPG debt repayment and when that starts?
Patrick Mahaffy
Dan will answer the TPG question in a moment, but Lindsey, perhaps you could answer the kind of the clinical result timing questions.
Lindsey Rolfe
Sure. So thanks for the question, Joe. Our estimation to readout from monotherapy, as you suggested, is guided by the current event rates. And so it have been pushed out a little bit because the events are coming more slowly than we anticipated when we designed the trial. So the monotherapy cohort, as you know, we expect that -- for the combination therapy part, we expect that to readout later. And right now, we're still using our protocol-defined assumptions to predict when that reads out. As we get nearer to maturity for the combination on, we'll be able to make more precise estimate of when the readout will occur. But at this stage, it's possible that it could go into 2023, but it's also possible to be earlier than the end of 2022. When we get near the time, we'll be able to estimate that much more precisely and perhaps if we can achieve that.
Dan Muehl
Joe, this is Dan. It doesn't have any impact on the TPG agreement. The timing of that is already set. So, as I indicated in my comments, we'll draw down the remainder of it, mostly between Q3 and Q4 of next year and that's when the payments start under -- in these area.
Joe Catanzaro
Okay. That's helpful. And if I could just ask the follow-up. I don't think I heard lucitanib mention anywhere. Are there still expectations to present data from the nivo cabo endometrial cohort later this year? And does the full approval of lenvatinib and pembro in this setting impact, how you think about the longer opportunity?
Patrick Mahaffy
Yes. We’ll – we may present later this year, data from an additional cohort. Obviously, on any commercial thoughts about lucitanib and further clinical thoughts about lucitanib are currently under review, and we’ll await data from cohorts that are still enrolling to inform that decision.
Operator
And at this time, there are no further questions. I would like to turn the call back over to Anna Sussman, VP of Investor Relations.
Anna Sussman
Thank you, Phyllis. We thank you all for your interest in Clovis Oncology today. If you have any follow-up questions, please contact me at 303-625-5022 or Breanna at 303-625-5023. The call can be accessed via a replay at our website beginning in about an hour and will be available for 30 days. We appreciate your interest and time, and thank you, and have a good day.
Operator
Ladies and gentlemen, that does conclude today's conference. We thank you for participating. You may now disconnect.
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Comments (1)
As expected, Pat using covid as an excuse for poor sales. Please dog, give it up that's last years excuse. Look at GBT - they used that excuse last year and got whacked but lo and behold their sales last q were smashing. No covid excuse for them.
Why the pps is holding up is beyond me, but I suspect this pos is going to $1 within a year (especially when Pat's covid excuses has run out). Strong sell
One last thing, as you can tell by the comments - NOBODY gives a rats azz about CLVS. Rightfully so.