Q1 2023 Deciphera Pharmaceuticals Inc. Earnings Call

Speaker 2: Good morning, everyone, and welcome to the CIFRA pharmaceuticals first quarter, twenty twenty three financial results conference call. Later, we will conduct a question and answer session to ask the question during the session. You will need to press star one one on your telephone. Today's call is being recorded.

Speaker 2: At this time, I would like to turn the call over to Jen Larson, Senior Vice President of Finance and Investor Relations. Jen?

Speaker 2: Thank you, operator. Welcome and thank you for joining us today to discuss Decipra's first quarter 2023 financial results. I'm Jen Larson, Senior Vice President of Finance and Investor Relations.

Speaker 2: With me this morning to discuss the financial results and provide a general corporate update are Steve Herder, President and Chief Executive Officer, Dan Martin, Chief Commercial Officer, Matt Sherman, Chief Medical Officer, Margarita Duarte, Head of International, and Tucker Kelly, Chief Financial Officer.

Speaker 2: Before we begin, I would like to remind you that any statements that we make on this call that are not historical facts are forward-looking statements made pursuant to safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Examples include our expectations of our preclinical and clinical programs, our commercialization of Kinloch, and 2023 guidance.

Speaker 2: Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statement, and we cannot assure you that our expectations will be achieved. Such risks and uncertainties include those set forth in our most recent quarterly report on Form 10Q as well as our other FAC filings. We assume no obligation to update or revise any forward-looking statements. Following this call, a replay will be available on the company's website.

Speaker 2: www.dacipha.com. With that, I will now turn the call over to Steve Herter, President and Chief Executive Officer of Decipha. Please stand for standing by.

Speaker 3: Thank you, Jen, and good morning, everyone. Thank you for joining us today as we provide an update from the first quarter, review our financial results, and look forward to the rest of the year. We're off to an exciting start for this catalyst-rich year and have already achieved a number of critical milestones that advance our mission to discover, develop, and commercialize important new medicines to improve the lives of people with cancer.

Speaker 3: previously treated with a mandolin.

Speaker 3: Based on these results, which showed a striking benefit for patients with mutations in kit X on 11 and 1718 treated with Kenlock. We plan to initiate the insight, pivotal phase 3 study of Kenlock in this patient population in the second half of the year.

Speaker 3: In March, we announced the FDA granted breakthrough therapy designation for Ken Lock for this population.

Speaker 3: This designation reflects the potential for Kenlock to offer substantial clinical benefit for this group of second-line just patients, and we believe it reflects the opportunity for Kenlock to become the future standard of care in this setting.

Speaker 3: The need for additional treatment options for just patients in the Post-Ampinant setting was further underscored by Ken Locks Inclusion and the National Comprehensive Cancer Network or NCCN, Clinical Practice Guidelines and Oncology as a preferred regimen for second-line just patients intolerant to synitonin.

Speaker 3: In March, we completed enrollment in the motion, Pivotal Phase III study, of himself and it, for the treatment of Phenocenovial Giant Cell Tumor, or TGCT, and we expect to report top-line results from this study in the fourth quarter.

Speaker 3: Together, Ken Lockend himself and him have the potential to benefit thousands of patients around the world with a peak worldwide sales potential of over $1 billion. We look forward to reporting the motion study results and initiating the Insights Study later this year.

Speaker 3: Most recently, at AHCR in April , we presented eight posters on our early stage pipeline, the most comprehensive demonstration of decipher his research in our company's history. These data highlighted the sustained productivity of our kinase switch control research engine, and its proven ability to generate product candidates.

Speaker 3: with first and best in class potential. We presented new preclinical data on our O.K. inhibitor DCC 3116, and combination with repretinib in just models, and in combination with Incarathenib and Citruxamab, and colorectal cancer models, that strongly support two new dose escalation combination studies.

Speaker 3: which we expect to initiate in the second half of this year. We also presented the first preclinical data for DCC 3084, a potential best-in-class pan-rapp inhibitor that broadly inhibits class 1, 2, and 3 B-Raff mutations and B-Raff fusions. We announced the nomination of our newest development candidate, DCC 3009, a potential best-in-class pan-kit inhibitor, and we showcased our newly announced research program focused on GCN 2 kinase.

Speaker 3: a key target in the integrated stress response pathway.

Speaker 3: from the first quarter. But first, I'll turn the call over to Matt Sherman, our chief medical officer, to discuss the Cypheros R&D efforts in greater detail. Matt? Thanks, Steve. We're through some progress we've made across our clinical and pre-clinical pipeline so far this year.

Speaker 3: X1-11 mutation and co-occurring X1-17 and or X1-18 mutations. This designation is a direct reflection of the substantial clinical benefit of KinLok in this patient population that we observed in the CT DNA analysis from the Intrigue Phase III study. Based on the Intrigue CT DNA data and regulatory input, we plan to initiate insight on new pivotal Phase III study of KinLok versus student-in-ed in this group of second-line GIS patients. In the second half of this year. If positive, we believe the results of the insight study will support an expansion of

Speaker 3: We also expect to present updated efficacy and longer term safety data from the phase 12 study of lymphocelotin that did the second half of this year that will continue to support the potential for lymphocelotin to be a best in class therapy in TGCT. Turning now to DCC 3116, we presented new and highly promising pre-comical data from 3116 in combination with reprittenate ingest models and in combination with encarapid and subtexting that and call a rectal cancer models at the AECR meeting last month.

Speaker 3: These data demonstrate that DCC 3116 can block and caratimate antidepressant-event-duse all-geactivation as well as the topology flux and B-Raff V600E-driven colorectal cancer pre-cuncle models.

Speaker 3: We also showed that 31-16 can block reprinted and induced all activation and topology flux and just preclinical models.

Speaker 3: In both cases, these in vitro results extend the positive and evil efficacy as demonstrated by tumor growth in the vision or tumor regressions and zina graft studies.

Speaker 3: We expect to initiate a new combination study evaluating DCC 3116-plus-encore affinant answer-touch-and-map in patients with colorectal cancer in a second half of this year.

Speaker 3: Under the clinical trial collaboration and supply agreement, Pfizer will supply and grafting at no cost.

Speaker 3: We also expect to initiate the new combination cohort evaluating 31-16 with repridden it in the second half of this year.

Speaker 3: Additionally, we plan to initiate one and more expansion cohorts in the second half of this year in combination with a Meccan Hibitors, Permanent Nip or Binny Metinip or the K-RAS G12C inhibitors, so the RAS did.

Speaker 3: The next program slated into the clinic is DCC 3084. We believe that 3084's potential best-in-class CANRAF inhibitor based on its profile is a potent and selective inhibitor of both BRAF and CRAF kinases, targeting all relevant abren signaling to RAF monomers, homodimers.

Speaker 3: and Heather Gimers.

Speaker 3: DCC 3084 exhibits high permeability, good CNS penetration, tumor tissue accumulation, and a long residency time, providing it with an excellent pharmaceutical profile that we believe will enable more durable efficacy.

Speaker 3: The strong preclunked advocacy and cancer models driven by RAF or RAS mutations support evaluation of both single agent and combination opportunities.

Speaker 3: We expect this is net 9D to the FDA in the second half of this year.

Speaker 3: Finally, I want to highlight the recent preclinical data we presented at AECR last month for PCC-3009, for the potential best in class Pan Kit and Hibiter.

Speaker 3: These data demonstrated its ability to potently and selectively inhibit the broad spectrum of known primary and secondary drug-resistant mutations in GIST models, spanning exons 9, 11, 13, 14, 17, and 18.

Speaker 3: This comprehensive in vitro profile also translated to exceptional in vivo results in which DFC3009 exhibited tumor regressions in multiple drug-resistant pre-clinical gist models.

Speaker 3: Like 3084, 3.009 also has optimized pharmaceutical properties, showing very high targets, and free drug levels, so enable exposures needed to suppress the broad spectrum of kidney patients and just.

Speaker 3: We expect for submit 9G to the FDA for DCC 3009 in the first half of 2024.

Speaker 3: As you can see, we have a lot to be excited about across our portfolio products with first or best in class potential, offering tremendous opportunities to be to benefit patients with cancer around the world.

Speaker 3: Thank you, Matt. In the first quarter, we continued to execute on our commercial goals for Kinlock in the US. We saw sustained strength in our core brand metrics, including prescriber reach and engagement, product awareness and perception, new prescriber growth, new patient acquisition, and average duration therapy. And our market research and K-Well interactions continued to highlight that Kinlock is firmly entrenched at the clear sense of care and pork line shifts. During Q1, net product revenue in the US was $24.6 million. This reflects the continuation of our strong core business.

Speaker 3: CAP and Gross-to-Net created headwinds for Q1Net revenue. Both CAP and Gross-to-Net were higher in Q1 of 2023 versus Q1 of 2022. Despite these headwinds to Q1Net revenue, strength in the underlying business, including positive volume growth, enabled a 5% increase in Q1Net revenue year over year. Looking ahead, we expect continued strength in the Kimlock business in the US. Our commercial team continues to execute at a very high level, again delivering the highest reach, frequency, and share voice of any company in the just market, and maintaining high awareness and positive product perceptions.

Speaker 3: among both academic and community physicians. New prescriber growth has continued at a consistent pace.

Speaker 4: again driven by community prescribers. We have now had over 900 unique prescribers in launch, the 75% of new prescribers in Q1 coming from community setting. New patient acquisition trends have also been very consistent and pay your access continues to be extremely positive.

Speaker 5: Aversuration of therapy increased to seven months since 2022, and we anticipated that it ultimately reached as high as 8-8-1-1-1-2-P.

Speaker 6: Moving forward, we expect that key growth drivers will include gradual volume growth of the average duration of therapy continues to mature over time, as well as continued net price growth.

Speaker 7: And despite a higher-pap percentage in Q1 of this year versus Q1 of last year, we continue to expect PAP to fall within our estimated 20-30% range throughout the rest of 2023.

Speaker 8: Our planned initiation of the study in the second half of the year is a key milestone for the cycle and importantly for patients who just. There is a significant unmet need for this patient population and if approved, we believe this additional indication would double the Kimlock P-Gravina potential to 350 to 400 million in the U.S. alone. While we continue to execute on our commercial goals for Kimlock in the U.S., we have also begun preparations for launch and self-med in TGCT, pending positive results from motion trial and FDA approval. We believe the site for a uniquely position to maximize this opportunity given that self-meds potentially best see-class profile.

Speaker 9: The strong relationships we have established with sarcoma traders in both academic and community settings, as well as the outstanding commercial capabilities that we have built. We believe in SELTENED will be a strong strategic fit for decyporous commercial portfolio.

Speaker 10: and will offer life-changing impact for patients living with TGCT. I will now turn the call over to Margarita Dwarke, our Head of International, to discuss the progress of the Kinlock launch in Europe . Margarita? Thanks, Dan.

Speaker 11: We are very excited with the continued launch momentum of Kingwark in Europe , and I am pleased to share that we are off to an excellent start in 2023. For the first quarter, international net product sales were 8.6 million, up from 5.4 million in the prior year, and even primarily by continued strong growth in demand in Germany and for us.

Speaker 12: This results reflect the strength of our launch, and I'm very proud of the hard work of the entire deciphered team to bring the first-present option to fourth-line GIFs to patient sensations in Europe .

Speaker 13: In Germany, I am pleased to announce that we successfully concluded our price negotiations and our final negotiated list price amongst 18,400 euros demonstrates the high value that Kinlock brings to G-Spatients in Germany. The final negotiated price for Kinlock is only 15...

Speaker 14: needs for patients in this setting. In France, we continue to successfully grow kinlock cells under the post-approval-paid access program as we make good progress in our price and reimbursement negotiations.

Speaker 15: We remain committed to working with NICE towards a positive outcome for advanced patients. And we are in discussions with the agency for a rapid review following the recommendation against the investment of Kinlock based on cost effectiveness, which is not uncommon. Additionally, we have made significant progress advancing our access discussions in Spain and Italy, and I am thrilled to share we expect to be in a position to launch Kinlock in Italy in the coming months. Since our European launch last year, we have achieved strong reimbursement ratings for Kinlock in multiple markets. Most notably in Germany, where reimbursement submissions are notoriously complex and where Kinlock was a...

Speaker 16: Collaboration revenue this quarter was comprised of product loyalty revenue under our agreement with Zai. loyalty revenue in Q1 was impacted by sales rebates, Zai provided to distributors in China for product that was purchased prior to a price reduction, following the inclusion of Kinlock in China's National Reimbursement Drug List in January 2023. Cost of sales were 500,000 in the first quarter of 2023, compared to cost of sales of 400,000 for the first quarter of 2022. In the first quarter total operating expenses were 86.7 million, compared to operating expenses of 76.1 million in the same period in 2022. Research and development expenses for the first quarter of 2023 were 54.8 million, compared to...

Speaker 17: and marketable securities were 426.3 million. With that, I'm now turning the call back over to Steve. Thank you, Tucker. We're proud of the significant progress we've already made this year and look forward to an exciting second half of 2023 with the announcement of top-line results from the Phase III Motion Study, initiation of the Phase III Insights Study.

Speaker 18: initiation of multiple combination cohorts for DCC-3116 in the filing of the NIND for DCC-384. As evidenced by a robust presentation at AACR, our proven discovery engine continues to generate new product candidates with first investing class potential, which we expect to fuel our future growth. With that operator, I would now like to open the call for Q&A.

Speaker 19: Thank you. Ladies and gentlemen, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To draw your question, press star 11 again. Please stand by while we compile the Q&A roster. And now first question coming from the line up.

Speaker 20: Tyler Ben Furn with Collin, you're on a supplement. Hey guys, good morning. Great to see all the progress. Thanks for taking a question. For Kidlock, can you just speak about what you're seeing commercially in the second line following the NCCM Guideline update? And I know it came late in Q1, but is this something that you expect to

Speaker 21: for patients with just in the second line who are intolerant to synodmin. It's really just too early for us to see any impact in our data. That's something we'll certainly continue to monitor and on future calls will provide updates as warranted based on what we see in the data. Thank you.

Speaker 22: as well as the patient assistance program. So based on that and the sales growth, is it reasonable to assume that patient volume growth is in somewhere around like a mid-single digit percentage year of a year? And the second question is to Tucker on R&D. First Coror R&D is higher than fourth Coror last year and obviously

Speaker 23: two questions. Let me kick us off first with respect to Kenlock and just make a couple of local comments and then I'll ask Dan to comment on the US business and then Margarita perhaps would like to offer some additional color on business outside of the US. So our view of the quarter is we had a really strong quarter of Kenlock revenue, very solid performance. Dan will comment on.

Speaker 24: the US dynamics that we see in the quarter. But the fundamentals, I would say, remain very solid here in the US. And of course outside of the US, we continue to prosecute additional pricing and reimbursement negotiations and to unlock market access and additional territories, which we think will continue to fuel future growth. So we're looking forward to seeing how the balance of the year unfolds, but I would say the fundamentals remain very close.

Speaker 25: that I described in the prepared remarks. But in terms of the underlying core business, we saw continued strength in all of our key metrics, including really importantly, new prescribed growth, new patient acquisition, average duration of therapy, payer access, and so on. And so overall,

Speaker 26: You know, definitely please with the progress despite the headwinds that we noted that relate to net revenue, we were able to grow net revenue 5 percent year over year. We have decided, you know, there are things that impact

Speaker 27: volume growth, month and month, quarter to quarter. So we plan to look at that, to evaluate that, to communicate on that with a somewhat longer time frame rather than quarterly. But I think we hope we've provided enough detail for you to appreciate the strength of the underlying business in the direction we're headed.

Speaker 28: reimbursement ratings that we have achieved so far, as well as all the progress that we are making with regards to market access to unlock new countries which will allow future launches. So actually geographical expansion is going to continue to be a strong growth driver in China and so making sure that trade moves are steadily growing to travel.

Speaker 29: And I would also say that the continued strengths of the current business in the countries where we have already accessed like Germany, like France, we also continue to play a key role in the success of Kimlock in Europe .

Speaker 30: It's Tucker on your question with regard to op-x. You're right, so op-x overall grew about 4% quarter of a quarter in Q1. As they said, they're prepared to mark. We would expect overall op-x to get a modestly increase to the balance of the year.

Speaker 31: As you noted, R&D increased in the quarter, GeneX was down a little bit. So it was a more sizable increase, but 14% quarter of a quarter of R&D, we wouldn't expect it to be that high going forward in the balance of the year. And as you look at the queue, you'll see that most of that was due to additional expense around Kinlock.

Speaker 32: on the on-dead front. So it will be quite as high overall for our D, but we would expect the balance of the growth over the year to be within on even one minus one.

Thank you. Thank you. And our next question coming from the line of Michael Schmidt with Guggenheim, Yelena Sophan. Hey, good morning. This is Paul on for Michael. I think they're taking your questions. I have two. The first is on Kinlock and potential guidance. So given some of the progress you've made in rocket access for Europe , do you have any plans?

and other approaches that are also in development for second line. It is a head to head against student sort of likely to remain at second line strategy, or are you considering other lines of just. Thank you.

Hi, Paul. It's Steve. Good morning. Thanks very much for the question. So let me take the first question that you had with respect to Ken Lock and guidance. And then I'll ask Matt to address your question with respect to 3-0-0-9. So first, in terms of guidance for Ken Lock overall, both for the base-fourth-line business.

based on the initial indication and the Invictus study. And then also the Insights study going forward in the second line. We earlier this year as a recall provided some peak revenue guidance for the brand. And what we saw the contribution being of the second line opportunity on top of the fourth line opportunity here in the U.S. So.

We see at peak in the US $350 to $400 million, peak revenue opportunity with those two indications combined. And that, of course, excludes opportunity outside of the US. And the reason we've excluded of you on that up until now is because we don't have clear your line of sight.

to what the average net selling price is going to be in Europe as we're still in the middle of pricing and reimbursement negotiations in key markets. Now we had some good news today certainly that we disclosed with respect to our German price and we're very encouraged to see that price and the recognition of value for the brand and the benefit that it offers to patients. But it's really too early for us to provide guidance in the nearer term just given some of the uncertainties around where we might end up on price in other territories. Matt? Thanks Stephen. Hi Paul. So in regards to your question about our new development candidate DCC3009, a pancit inhibitor, of course we're very pleased with the activity we have with Kinloch in the fourth line setting.

And now with the emerging data that we're able to show by the CTDNA analysis for Kimlock in the second line patients who harbor the X-on 17-plus X-on 11-plus 17-degree T mutation. And again, one of the patients is not so group, but very strong activity. Of course, there's other opportunities in the just space for a pan-kin inhibitor, such as 3-0-0-9. And that can be another one to therapy, either as a single agent or also as potential combination therapy.

So as we get close to filing the IND, we look forward to sharing more about our development plan with that molecule.

We look forward to sharing more about our development plan with that molecule. Great. Thanks so much.

Yeah, Brad. Thanks for the two questions. Let me take the pan kit question, the 3009 question that I'll ask Matt to comment on 3084 and a pan wrap inhibitor. So we're excited to make the disclosure at AACR about 3009 as a broad spectrum inhibitor with really exquisite selectivity and very favorable pharmaceutical properties. We have, as you know, a lot of experienced developing drugs in GIST. We have, I think, treated the largest number of patients on clinical study with GIST of any biotechnology or pharmaceutical company. And along with that comes a lot of additional data that we have access to from patients enrolled on this study.

Maybe just to start off, we've got the negative nice opinion. I would love to kind of hear what the dialogue is at this point. And when do you think the UK might kind of enter the picture, again, as you evaluate the European opportunity? And just while we're thinking international, can you just talk a little bit about the expectations, XUF, XEU? How is the launches in the other countries going? Sure, good morning, Ren. Thanks for the picture, really good questions. I'll ask Margaret to comment on the nice development and our progress there.

for England and Wales. Marguerita. Sure. Thanks, Steve. Let me start by saying that since our launch last year we have achieved some of the best possible investment ratings in Europe . It's not the very best which was the case in Germany. So when it comes to NICE, NICE has a specific way of decision making when it comes to NICE.

we will be able to resolve the outstanding questions enabling launch in England and in Wales in the future. So I would say this is currently the discussions we are having with the agency and we remain confident that we will be able to.

to turn around the current situation with night. And then, Ryan, I think the second question that she had relates to generally speaking outside of Europe , outside of the US, how we're thinking about the opportunity and those territories. And I would just offer that we continue to make really a progress. We have a distribution partner for Australian users.

for the company going forward. In the quarter, as Tucker mentioned in his prepared remarks, the good news is that the drug is now on the National Drug Reimbursement List in China. So we expect to see over time that be a contributor to our overall royalty revenue and the collaboration revenue that we've reported on.

It's a substantial market. Dye is going to have additional data from their experience in the clinic with Ken Lock and Chinese subjects coming up at the ASCO conference. And we believe that China will continue to contribute overall to our financial performance as a company. But we saw some add winds in the quarter just based on

the rebates that Xi had to provide to distributors in China associated with the national drug reimbursement listing in that country. So we'll continue our work to find markets outside of the US where we can continue to introduce the product to patients and also to generate revenue for the company.

Got it. And just maybe switching gears real quick to them self-inhab. You know, assuming that the trial is positive, can you talk a little bit about, you know, what kind of pre-commercial activities, you know, have been initiated? I think then, as prepared the Marx mentioned, you know, that you've already started some pre-commercial activities, any color there. And then, you know, again, assuming that it's positive is one ice.

The data update that we had as the last year clearly shows the potential for them to be nested in class for the treatment of patients with TGCT. We previously reported what we see as the prescriber overlap in the US, which we think is quite high. We also outlined what we see as the market opportunity in the US for themself in it. The fact that physicians, when we test blinded product profiles, they continue to select themself as the blinded profile that they prefer to use for the treatment of the patient. So we're excited to get to the data read out. You're coming up in Q4 from the Motion Study and we think that the liquidity of the involvement in motion also underscores the unmet need in this population globally, both in the US as well as in Europe .

Maybe you want to comment specifically on some of the early commercial activities. Yeah, absolutely, Ren. Thanks so much for the question. So as I mentioned in the prepared remarks, we really think that the cipher is uniquely positioned to take advantage of this opportunity. And that speaks to a number of things, not the least of which is transition, right?

what we believe to be a likely best in class profile for Feltened. And then in addition to that, as you know, we've been working really closely with sarcoma treaters in the academic setting, community setting for quite some time now, and really built tremendous relationships with them. And importantly, we've also built real, I think, best in class capabilities.

to commercialize rare tumors, really successfully. We've done that, demonstrated that with GIFT, and we are now in the process of getting ready to port over those capabilities to TGCT. So we're in the relatively early days of building up that engine.

identifying the team, identifying at launch plans, thinking through how we will extend the capabilities that we've built for GIF to TGCT. We likely wouldn't be expanding the sales force. First of all, we don't think it's going to require a major expansion. One of the things we've talked about.

Previously is the synergy that this second product provides. But whatever incremental ads we may make will come a bit down the road and we'll certainly speak to those when we get there. But as we get closer to launch, there will certainly be a lot of educational aspects that go on. And it's not just a commercial team that will be.

very engaged in this, obviously the MetaFair's organization will be as well. So, lots going on, very exciting time and work on. Great. Thanks for taking the questions. Thank you. And, Asa Minda, if you'd like to ask a question, please press star 11. And our next question coming from the line up.

potentially moving them into that setting. Hi, Andy. Yeah, now it's a great question. Of course, our focus today has been on the TGCT patient population for themselves and if we do believe it can be a best in class CSF1 receptor inhibitor in necklopatients based on the phase one to data that we last updated asmo in September last year. And of course now with full enrollment, the motion-based behavioral study and the readout for top-line results. But of course, you know, for any product we are certainly alert and aware of potential electrical management and other indications. As you mentioned, graphic source disease has been a disease where CSF1 inhibition has shown activity. So of course, as we think through our entire program, there will certainly be other opportunities.

So, we cannot share with you in the future. Okay, thank you. Thank you, one moment for our next question.

And our next question coming from the line of Peter Lawson with Barclays, your line is open. Hi, good morning. This is Shaycian for Peter Lawson. Thanks for taking our questions. One from our team here is how we should be thinking about the contribution of being incorporated into the NCCN guidelines for the rest of 2023. Appreciate that you can't.

promote awful-able use and it's a bit early to tell progress from one queue so far. But maybe how we could think about it for the rest of the year and whether we should be expecting that the guidelines would be updated to reflect clinical data for the benefit in X-11, 17-18 subgroup and maybe any sense physician sentiment around using it ahead of insight data. Thank you.

that we can or will promote to. So we'll continue to monitor the market dynamics over time and try to understand whether we're seeing utilization, spontaneous use here in the US as a result of that guideline listing. And to the extent we see breaks in the trend, then we'll certainly report that and provide additional color on a go-forward basis. It's really difficult for us to predict, as we sit here today, what use, if any, might occur as a result of the compendial listing with the NCCN. For the 11, 17 or 18 use in the second line based on the data we reported at the ASCO plenary series earlier this year. And now the subject of the Insights study, which we expect to kick off later this year. The NCCN, of course, can make updates to the guidelines at any time. So we'll be curious to see.

to what extent the NCCN decides to make guideline updates based on those data. As Matt mentioned in his prepared remarks, there will be a reprise of those data presented at ASCO in June , at the end of this month, in June . And we look forward to that data presentation and also to seeing if there are any additional changes that occur in the treatment guidelines.

Thank you. And I'm showing no further questions at this time. I would now like to turn the call back over to Mr. Seyporta for any closing remarks.

Great, thank you very much. Thanks everyone for joining us on today's call. Thank you for your continued support. And we look forward to keeping you updated on our continued progress here at the Cypher. Have a great rest of your day.

Please, and gentlemen, a thousand out of conference for today. Thank you for your participation. You may now disconnect.