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spk09: Good day and welcome to the NovaCare Q2 2022 earnings call. After the speaker's presentation, there'll be a question and answer session. As a reminder, this call is being recorded. I would like to turn the call over to Ingrid Goldberg.
spk11: You may begin. Good morning, everyone.
spk01: And thank you for joining us to review NovaCare's second quarter 2022 performance. I'm joined on the phone by our Executive Chairman, Bill Doyle, our CEO, Asaf Donziger, and our CFO, Ashley Cordova. Other members of our executive leadership team are also on the call and available for Q&A. For your reference, slides accompanying this earnings release can be found on our website, www.novacure.com, under quarterly reports on our investor relations page. Before we start, I would like to remind you that discussions during this conference call will include forward-looking statements, and actual results could differ materially from those projected in these statements. These statements involve a number of risks and uncertainties, some of which are beyond our control and are described from time to time in our SEC filings. We do not intend to update publicly any forward-looking statement except as required by law. Where appropriate, we will refer to non-GAAP financial measures to evaluate our business, specifically adjusted EBITDA, a measure of earnings for tax, interest, depreciation, amortization, and share-based compensation. We believe adjusted EBITDA is an important metric as it removes the impact of earnings attributable to our capital structure, tax rate, and material non-cash items, and best reflects the financial value generated by our business. Reconciliations of non-GAAP to GAAP financial measures are included in our press release, earnings slides, and in our Form 8K filed with the SEC today. These materials can also be accessed from our Investor Relations page of our website. Following our prepared remarks today, we will open the line for your questions. I will now turn the call over to our Executive Chairman, Bill Doyle.
spk02: Thank you, Ingrid, and good morning. Our mission at NovoCure is to extend survival in some of the most aggressive forms of cancer through the development and commercialization of our innovative therapy tumor treating fields. The second quarter was a period of solid execution and progress. Revenues were up 6% compared with the second quarter of 2021. We released encouraging Phase II data in gastric cancer and announced a second partnership with global oncology leader Merck. As we approach a series of pivotal milestones in the coming quarters, we feel a hum of excitement at NovoCure as our teams work toward data readouts and develop launch plans. We exited the quarter with 3,000 454 commercial active patients on TT Fields therapy around the globe. Steady patient volumes in the U.S. and increasing adoption in Japan offset a decrease in German active patient numbers as a result of updated coverage criteria. We are pushing a number of avenues intended to increase the adoption of TT Fields therapy and reach more patients who may benefit from TT Fields. In GBM, Our focus is to drive greater adoption in academic institutions where we see a significant share of GBM patient flow. We are employing a multi-pronged strategy to engage practitioners in the academic setting to ensure they understand and can communicate the broad benefits of TT fields. One of the most effective ways to drive greater adoption is with the ongoing generation of clinical data. Year to date, There are over 1,500 PubMed citations of PT fields, pointing to the increasing relevance of PT fields in the scientific community. Also this quarter, two key clinical data sets were presented, which we would like to highlight. External research intended to identify genomic factors associated with an increased response to Optune was published in the June volume of neuro-oncology. Retrospective data were collected from 148 patients treated at six leading academic institutions. Consistent with the findings of the EF14 randomized phase three trial and other independent data sets presented to date, the use of Optune increased progression-free and overall survival in all patient cohorts. and demonstrated a clear dose response with increased usage. Beyond the broadly applicable benefit, alterations in certain genetic signatures were associated with increased benefit from Optum. These results further validate the survival benefit for GBM patients shown in the EF14 trial and shed light on potential predictive biomarkers associated with an even greater response. opening an interesting area for ongoing research. At ASCO in June, the Charité University Hospital in Berlin presented a multi-country registry analysis of GBM patients in Austria, Germany, and Switzerland. The Charité analysis of real-world evidence showed a median overall survival of 35 months for patients treated with Optum plus chemotherapy compared to 15 months for patients treated with chemotherapy alone. These registry data further underline the benefit of Optune with real-world experience and are consistent with the results we have observed in more than 25,000 GBM patients treated with Optune to date. The growing engagement and research on Optune and PP fields emanating from leading academic centers is very encouraging, and we believe indicative of the growing awareness and acceptance of tumor-treating fields therapy. While we are preparing to launch in new cancer indications, we are committed to investing in GBM treatment innovation. To this end in May, we announced a second clinical collaboration with Merck. Together, we plan to conduct a double-blind, placebo-controlled pivotal study of TT fields together with pembrolizumab and temozolomide for the treatment of newly diagnosed GBM. This study will build upon the research recently published in the Journal of Clinical Investigation and will seek to confirm the promising data generated by Dr. David Tran's To the Top Phase II study. This latest collaboration between Novacure and Merck will continue the exploration of PT fields together with immunotherapies in a malignancy and in a region of the body where checkpoint inhibitors have not previously shown a therapeutic benefit. We are also exploring other new GBM treatment protocols. Our pivotal Trident study is evaluating the benefits of starting TT Fields therapy concurrently with radiation therapy rather than following radiation therapy. 96 clinical sites are actively recruiting patients for Trident. Beyond clinical data and physician education, patient awareness is also critical to expanding adoption. We recently finalized a Opt for Optune social media campaign, which is scheduled to launch in the second half of this year. By engaging patients, caregivers, and physicians across the digital ecosystem, the Opt for Optune campaign is designed to instill confidence, inspire courage, and prepare, guide, and support patients on their GBM treatment journey. Just as other physical treatment modalities evolved from their invention to their ultimate optimal use, we are making significant investments in product development as we seek to further improve outcomes. Array layout planning is an essential component of treatment with Optum, as it allows the prescriber to optimize the intensity of therapy by adapting array configuration for each patient. Today, The Novotel system is used to create these individualized treatment plans. MaxPoint is our next generation array layout planning system. MaxPoint is designed to provide more precise targeting to increase the intensity of PT fields delivered to the tumor. This quarter, we advanced MaxPoint development with the initiation of an evidence generation program, which compares the dose volume metrics of MaxPoint guided array layouts to Novotel guided array layouts. We look forward to sharing data from the MaxPoint program in coming quarters. Additionally, our next generation arrays, now known as the FlexArray, remain on track for a limited market release in Europe this year. We believe these arrays have the ability to deliver a higher, more consistent intensity to the tumor bed without meaningfully increasing heat Both the FlexArray and MaxPoint represent meaningful milestones in our product development journey and highlight our commitment to ongoing investment in product development initiatives. Beyond GBM, we are exploring the use of TT fields in a number of additional solid tumor indications in the torso and abdomen. In June, together with our partner XyLab, we presented data from the EF31 pilot study. EF31 evaluated the use of PT fields together with chemotherapy for the treatment of gastric cancer. Gastric cancer is prevalent and deadly, with five-year survival rates below 20%. We were excited by both the response rate and the durability of responses shown in the EF31 data. demonstrated an objective response rate of 50% and duration of response of 10.3 months, both notable improvements over historical controls. We are very pleased with the signals generated from EF31. We are eager to continue exploring the potential benefit of TT fields together with standard of care therapies in a large, randomized clinical study. Looking to the future and turning to our clinical pipeline, we are entering a period of potential transformation. We have four Phase III clinical trials in new indications poised to read out in the near term. If successful, these readouts could increase the number of patients eligible for TT fields by approximately 14-fold. LUNR is our next pivotal trial to read out. As a reminder, LUNR is the first randomized study in our thoracic program and evaluates the use of PT fields together with docetaxel or physician's choice PD-1 inhibitor for the treatment of stage four, second line, non-small cell lung cancer. We completed enrollment of LUNR and commenced the final patient's 12-month follow-up in November of 2021. Given feedback received from all interested parties, We recognize a pivotal trial data release during the final week of the year is not ideal for investigators, clinicians, investors, or potential patients. For that reason, we will be moving the top-line data announcement to early Q1 2023. To be clear, our clinical operations and data collection efforts remain on track. This decision to push the announcement was made to ensure optimal visibility and convenience for all audiences. Innovate 3, our pivotal study in recurrent ovarian cancer, is on track for a 2023 data release, following an 18-month follow-up from last patient enrolled. As a reminder, we announced the completion of enrollment of Innovate 3 during our Q3 2021 earnings call. METIS and Panova 3 continue to enroll patients in line with expectations. We are pleased with the progress made in the second quarter. The updates this period represent deliberate steps to strengthen the fundamentals of our business and to plan for pending data releases and potential expansion into new large indications. We remain excited and inspired by the prospect of treating many more patients in the near term. I will now pass the call over to Ashley to run through our second quarter financial performance.
spk07: Thank you, Bill. The second quarter was another period of strong financial performance, with gross profits from the core GBN business, funding investments, and clinical and product development as we advance the tumor treating fields platform. I know you have seen our press release in 10-2 this morning. So let me provide a few brief highlights regarding the financials. Revenue was strong, up 6%, with 3,454 global active patients on therapy as of June 30th. Bill spoke to the broader adoption trends earlier on this call, so I will focus now on revenue, and in particular, the dynamics in Germany. As a reminder, in Q4 of last year, we announced that we reached agreement with the largest public German payers on a price for Optum. This year, we formalized terms with payers that represent approximately 70% of the covered lives in Germany. These contracts will enable price stability and provide a strong pricing foundation as we pursue reimbursement in additional European markets. The negotiations impacted our net revenues as some payers withheld approval for new patients and began to deny approval for many active patients under the coverage criteria established in the DME listing. We expect revenue to grow over time as more patients are treated under the updated contract terms. In the U.S., The exceptional execution of collections processes provided a material tailwind to revenue in the second quarter. Revenue operations is a core competency at NovoCure, and the U.S. business is benefiting both from collections on previously denied and appealed claims and from an increase in the average price realized for current active patient volumes. Strength in the U.S. price was more than sufficient to offset the headwinds from Germany and foreign exchange. Gross margin for the second quarter was 80%. Excluding purchases made by Zylab, our cost of revenues per active patient per month was down 5% year over year, as any impact from broader economic challenges was more than offset by continued proactive work to optimize our supply chain alongside other cost reduction initiatives. we did not experience a material impact to our cost of revenues from inflation in the second quarter. SG&A expenses for the second quarter totaled $76 million, an increase of 14% year-over-year. G&A expenses decreased year-over-year due to lower spending on corporate enabling functions, while sales and marketing expenses increased to support geographical expansion and early commercial marketing activities as we approach multiple pivotal data readouts. We invested $57 million in research and development in the second quarter, an increase of 13% from the same period in 2021. R&D dollars are one of our best uses of capital, and we are investing aggressively in projects across our preclinical research, clinical, and product development verticals. Our net loss for the second quarter was 23 cents per share for $24 million. Adjusted EBITDA was $7 million, and we finished the period with $949 million in cash and short-term investments on the balance sheet. We believe our cash position ensures we can pursue growth opportunities across the business with maximal flexibility. Novocare's financial foundation is strong. and our commercial execution is secure and stable. We will continue investing aggressively in the tumor treating fields platform so that we are prepared to fully leverage the outcome of multiple pivotal trials and potential subsequent launches in the coming quarters. With that, I will pass the call to Asaf.
spk08: Thank you, Ashley. This quarter, we continued to advance our mission of extending survival in some of the most aggressive forms of cancer. Our commercial team is focused on driving adoption of . We see mounting clinical support for our therapy, both from internal and external researchers. As we approach readouts from several pivotal studies over the next year, we are motivated by the prospect of treating many thousands more patients in the near future. I would like to thank my NovoQ colleagues for their passion and determination in advancing the science and adoption of city fields. We have made immense strides in recent years, but we have only just begun our journey. I know as we move forward, you will all keep our patient forward mission in your hearts and minds. To close, I would like to share a patient story. In 2019, DJ Stewart was an avid skateboarder who spent his free time surrounded by family and friends. DJ was set to start a new job, had just become engaged, and bought a house in Kansas City. In May of 2019, DJ had a seizure and was rushed to University of Kansas Medical Center, where he was diagnosed with GBM and prescribed Optium. DJ's GBM journey is the focus of the documentary Rare Enough. I encourage all of you to watch this short film. Rare Enough takes you through DJ's diagnosis and treatments and includes candid reflections on his GBM journey, which are both heartbreaking and inspirational. DJ recently joined Head for the Cure, a charity focused on inspiring hope in the brain cancer community. It is patients like DJ that drive our company forward every day. With that, I will now turn the call over to the operator for Q&A.
spk09: As a reminder, if you'd like to ask a question, please press star 1-1. Our first question comes from Corey Kasimov with JPMorgan. Your line is open.
spk05: Hey, good morning, guys. Thanks for taking the questions. I have two of them for you. First, on the commercial side, I believe you previously guided to 2 to 5% active patient growth for fiscal year 22. Are you still confident in that number? And if so, what do you expect to be the primary driver or reacceleration in the second half? And then secondly, on the clinical side, just in terms of next steps for gastric cancer, Any comments yet on what a pivotal trial might look like and the breadth of it? Would you be looking to target just HER2-positive patients, or do you have a broader strategy for this indication in mind? Thank you.
spk03: Great question.
spk05: This is Bill.
spk03: I was going to just start by saying our team is gathered virtually today from points all over the world, so I'm going to be a little bit of the emcee. And I'm going to turn it over to Ashlyn to take your first question, and then Uri will talk about the gastric trial.
spk07: Perfect. Thanks, Corey. So just to tee up, ex-Germany, our active patient growth year over year was 3%. Asian and other European markets remained strong and were focused, as we've talked about, on a variety of commercial drivers in the U.S. But given the abrupt fluctuation in German active patient volumes, we are not providing forward-looking cover. It's just we don't have a clear enough line of sight as to the face of recovery in Germany to reiterate that two and five percent.
spk11: Okay, thank you.
spk05: And yeah, that's great. And then on the gastric side?
spk13: On the gastric side, so EF31 was our first study in gastric cancer, which as a high incidence, especially in Asia, of course, but an incidence anticipated to rise also in the U.S. And the study was designed for patients with unresectable disease who received their first-line therapy concomitantly with TTP to the abdominal region. And beyond the very strong signal of efficacy which the study provided, we're always encouraged by the fact that we have another evidence supporting the broad applicability of TTPs in yet another region. So we certainly anticipate a Phase III study in the coming time. We are considering the design of the study, given the fact that nivolumab has demonstrated efficacy in this malignancy through the Checkmate 649 study. We are seriously considering having another study incorporating immune checkpoint inhibitors in another malignancy going to be the 607 study to involve the immune checkpoint inhibitors with tumor-treating fields.
spk05: Okay, that's helpful.
spk11: Thank you. Our next question comes from Jason Bedner with Piper Sandler.
spk09: Your line is open.
spk14: Hey, good morning. Thanks for taking the questions here. Wanted to start with the lunar update. This really sounds like just entirely wanting to make sure the top line data gets as much attention as possible. And isn't it all related to data issues or data collection? But if I can push you a little bit and just to be a little blunt, if this is just top line data and not the full data set comparing all the different arms of the study, does the timing of the headline data really matter? And maybe you can talk about what changed in your view to drive the shift in timing that's been in place now for several months.
spk03: Yes. Good morning, Jason. So thanks for the question. I want to underline what I said in the prepared remarks, that this slight shift has nothing to do with any trial issues or operational issues. We heard loud and clear from essentially all of our constituents THAT ANY DATA ANNOUNCEMENT BETWEEN CHRISTMAS AND NEW YEAR JUST IS NOT DESIRABLE. AND SO THIS IS PURELY FOR THE CONVENIENCE OF OUR STAKEHOLDERS TO PUSH THIS INTO EARLY Q1. OKAY.
spk14: ALL RIGHT. UNDERSTOOD. I GUESS I'LL SQUEEZE TWO IN HERE ON A FOLLOW-UP. FIRST, JUST AN EASY QUICK HOUSEKEEPING ITEM. On the revenue side, can you size the previously denied Medicare claims that you referenced? You know, what impact was that in the second quarter? And then, you know, maybe a bigger picture on Germany, you know, maybe expand on what's changed more specifically with respect to the reimbursement dynamics in that market and the coverage dynamics. Is it just newly diagnosed patients that are being, you know, treated and covered and the recurrent GVM patients that are no longer covered by some payers? Just, you know, what shifted in those coverage dynamics that you alluded to. And then for the active patients that are now being denied therapy and care, can those come back into the fold as treated patients? It doesn't sound like they can just from the way you answered Corey's question, but I guess really just what's the best way to think of the current active patient figure in Germany with respect to the run rate here going forward? Thank you.
spk07: Yeah, thanks, Jason. I appreciate the question because it is important for everybody to understand these puts and takes. So I'll start with the U.S. strength, which is a bit of an easier story, right? So we anchored everybody, I'll remind you, to the Q4 2021 price as a stable and durable price. So if we look at the you know, if we look at the tailwinds versus that price in the U.S. in the second quarter, I would put about two-thirds of it to aged and previously denied claims and about one-third to the strength in the fundamental business. So that's how I'd put it out relative to Q4 of last year, which is a good baseline. So then if we shift over to Germany, let me spend a bit more time on this question because I know it's new this quarter and important for everybody to understand. If we take a step back, I'll just... remind everybody that we've been working purposely towards coverage and pricing in Germany via an established reimbursement pathway for years now. This is important because having coverage and contracts with major payers in Germany will enable price stability and a strong pricing foundation as we pursue reimbursement in other European markets and in Germany and other indications. Similar to Medicare, this is a significant milestone as we are the first life-saving, life-extending oncologic therapy to seek a DME listing in Germany. So if we look at the milestones along the way, in March 2020, the GBA issued a directive mandating coverage for Optune in line with the EF14 protocol. In Q4 of last year, we announced that we had reached agreement on a price for Optune with the largest German payers. And then importantly, earlier this year, we now have official DME listings. And as of the end of the quarter, we have formalized contract terms with payers representing 70% of covered lives in Germany. So that's the background context. But then when we look at what specifically happened in the quarter, Prior to the DME listing, many of our payers were approving Optune on a case-by-case basis, and they were not confirming coverage criteria in line with the EF14 protocol. With this newly established DME listing, we had many payers withhold approval for new patients and begin to deny approval for existing active patients if they did not cleanly match the EF14 protocol, and that did represent a material portion of our existing active patient business. We did not take any of those patients off therapy, of course, but we adjusted our process in Germany during the second quarter to ensure compliance with the DME criteria prior to a patient's start. But given the recurring revenue stream we have and the duration of therapy, which can extend a year or more, we now have a challenging patient mix as less than 15% of our active patients started under this new coverage review process. And as a result, we have both the updated price, but also a lower portion of our active patients covered under the new terms. So that's the background in the quarter, but just looking ahead now, we have clear line of sight to which patients will be approved. We have established DME policy. We have established payer terms. We've adjusted all of our processes to ensure compliance with these, and I do expect that the patient starts and the patient mix will improve each quarter from here, and revenue will return over time. But this will play out over the course of several quarters, just given the duration of therapy that we have. That was a long-winded answer, Jason, but I think important to kind of walk through, so happy to take any questions if additional clarification is necessary.
spk14: Yeah, no, I'll have that in queue. That was very helpful, actually, and we can follow up offline with others. Thank you.
spk07: Perfect. Thanks.
spk09: Our next question comes from Greg Frazier with Truist. Your line is open.
spk04: Good morning, folks. Thanks for taking the questions. Ashley, can you talk about what's driving the higher price in the U.S.? And how should we think about net revenue per month in the U.S. going forward? I think your comments that you made were on a global basis, but if you could provide some color on the U.S., that would be helpful.
spk07: Yeah, again, thanks for the question, Greg. So if we look at the U.S. strength and price, it comes from two primary buckets. One is success on previously denied and appealed claims. This is about two-thirds of the strength in that U.S. price if you look versus the Q4 2021 baseline, which is our anchor price. And about the remaining third comes from fundamental improvements in expanding coverage policies at the margin and just price negotiations with additional contract players over time. So I would say a third of it is durable and really related to just ongoing market access work. And two-thirds is really the performance of our U.S. revenue operations teams as we continue to go after those aged claims that we have in the pipeline. I will remind everybody that the predictability of those aged claims is not high, and so when we look ahead, I would bank on the enduring improvements and not the aged claims.
spk04: Understood. On Japan, prescriptions declined, although the active patient number grew. Can you talk about demand trends that you're seeing there, and are you headwinds to prescribe in Japan?
spk03: Go ahead, Pritish.
spk12: Thank you, Bill. Greg, thanks for the question. So, the short answer is we're not seeing any new headwinds. I would say that's just the cyclical nature of how we see within a rare disease like GBM, prescriptions flow through. So we would expect just based on the historical performance in Japan, the strength of our data, and our ongoing efforts there, the business will continue to be stable in Japan. Got it.
spk11: Thanks for taking the questions.
spk09: Our next question comes from Emily Bodner with HC Wainwright. Your line is open.
spk10: Hi. Thanks for taking the questions. I just had one on your next generation arrays that you plan to launch later this year in Europe. I guess, what are you looking to see with the initial launch to kind of determine if you want to take that out more broadly? And what would you want to see in order to potentially implement that into the label for Optune? Thanks.
spk03: Yeah. So, thank you, Emily. Again, taking a step back, with device-delivered therapies, the first incarnation of the device is almost never the final incarnation. Improvements can be made through engineering to optimize the usability and the therapeutic benefit. You can think of almost any medical technology And you can see the progression. We believe we're in the earlier innings in terms of the form factor and the ability of our device to help patients. And the next major step forward is with the new arrays that we anticipate to launch in Europe later this year. What we're looking for really is to test all of our systems. This is a major change in form factor, so we have to update all of our manufacturing capabilities so that we can serve all of our markets. We are going to look to patient user factors to make sure that we have the right instructions for use and that our people are well trained to bring this new therapy to patients. And you always look for surprises. We don't anticipate any, but that's the nature of the word surprise. They're not anticipated. And if we do see something that's surprising, we can take whatever steps are needed in instructions for use or in manufacturing to overcome whatever the surprise may be. So I can't overstate how excited I am about this development. And as soon as we get the experience from the initial launch, we'll incorporate that into our regulatory plan throughout the world.
spk11: Okay, got it. Thank you.
spk09: Our next question comes from Jason Witt with Luke Capital. Your line is open.
spk06: Hi, thanks for taking the questions. Just first a clarification on the U.S. strength and the denied claims. Was that all Medicare? Was that a mix of Medicare and private? Or could you give some indication of where those denied claims that were remedied came from?
spk07: It's a mix, but it's largely Medicare. That's where our largest opportunity is in the backlog.
spk06: Great. That's fair. And on the Merck trial for GBM with checkpoint inhibitors, As you mentioned, checkpoint inhibitors have not been effective for GBM. I take it there's evidence that they do pass the blood-brain barrier and they are present around the tumor. Is that the right assumption?
spk03: Laurie, do you want to just give a little background on our work with checkpoint inhibitors in the brain?
spk13: Yes, of course. As you remember, there is a growing level of evidence demonstrating that concomitant use of tumor-treating fields and immune checkpoint inhibitors actually leads to a greater inflammatory anti-tumor reaction against a tumor. And this has been demonstrated throughout the work of our own in-house lab, but also through the work of other external collaborators, one of which is Dr. David Trent, from the University of Florida and his publication at the JCI really showed how you could potentially achieve innate immune response and later adaptive immune response with the generation of memory response against the cancer. So that's on the scientific preclinical side. But at the same time, there is more and more evidence that on the clinical side, we see that effect. And one such preliminary evidence is coming from the TUDA-TOP study, where the concomitant use of Keytruda, Tembrolizumab, with CT fields led to a significant increase in median overall survival. This is a single-arm study, but the concomitant matched control comparison already showed that while the to-the-top study population achieved a median overall survival of 25.2 months, on year 14 matched controls, it was about 10 months less of the incorporation of immune checkpoint inhibitors to Optum in the intended use or approved indication led to a significant improvement. So it's true that immune checkpoint inhibitors have unfortunately failed to demonstrate efficacy in newly diagnosed and recurrent GBM, but it seems that their potential penetration across the blood drain barrier be it lower or decreased, still results in a very significant immune response and leads to a clear clinical benefit coming from this study, and that is the basis for the planned Kino-D58, our second clinical collaboration with Merck, with MSD. The first was in northmost lung cancer, And we're looking forward to conducting this phase three pivotal study. Great.
spk06: Those are helpful. And also, I think I heard correctly that you mentioned for the GASTR trial that you did look at genetic differences. Is that something that may lead to future screening for potential patients for TTF? Or could you expand upon, you know, kind of what the indications were when you looked at that criteria? Yeah.
spk13: So the EF31 gastric study was a small single-arm study for about 25 patients, and we did not take the opportunity to look into genetic variations in this patient population because of the preliminary nature of the study design and the number of patients included in the study. And despite the fact that we see this, especially GBM to date, of course, that TTC is effective in a really broad patient population. And as you recall, in year 14, we broke it down to different subpopulations, whether it's MGMT promoter, methylated or unmethylated, older patient population, younger patient population. At the same time, we always try to see if there are subpopulations that could benefit more from TT Fields and we are planning to do this on the immune response front, collecting more data and trying to characterize the immune response and see how we could potentially increase it. And also when it comes to genetic variations and alterations at the level of the tumor itself. And one key project that came actually from the post-approval setting and was published in Advances in Neuro-Oncology recently, demonstrating by independent investigators in the U.S. in several different centers that certain genetic alterations correlate very well with improved outcome in newly diagnosed GBI. So again, the treatment itself is effective in the broader population, but we're always trying to find biomarkers and other and findings that will support the identification of patient population that could generate even improve the outcome from applying TPCLs.
spk11: Thank you very much. I'll jump back in queue. Our next question comes from Vijay Kumar with Evercore. Your line is open. PJ, I don't think we can hear you.
spk07: Not operating, perhaps we'll go back to the queue. All right, Michelle, we can go back to the queue.
spk09: There are no further questions. I'd like to turn the call back over to Bill Duell for any further remarks.
spk03: Thanks, Michelle. I'd like to thank everyone on the line for joining us this morning. I'd also like to join ASAS and extend my thanks to the Novacure employees who have dialed in. I know I speak for myself, ASAS, and for the entire management team when I say we appreciate the hard work and dedication. We're very pleased with the progress this quarter. We continue to take deliberate action to strengthen the fundamentals of our business and prepare for the future. The science behind tumor-treating fields continues to grow, and in the coming quarters, We will have pivotal data from a number of our late-stage trials. This is an exciting time at NovoCure, and we look forward to updating you on progress in the coming months. Thanks again.
spk09: This concludes the program. You may now disconnect. Everyone, have a great day.
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