Q1 2025 Day One Biopharmaceuticals Inc Earnings Call
Andres Maldonado, John F.
Hello ladies and gentlemen, and welcome to the day one biopharmaceuticals first quarter of 2025, Financial and Operating Results Conference Call.
At this time, all participants already listened only mode.
Speaker Change: Later, we will conduct a question and answer session. Please be advised that this conference call is being recorded. I would now like to turn the call over to Joey Perrone, Senior Vice President of Finance and Investor Relations.
Please don't please stand by.
Speaker Change: Ladies and gentlemen, thank you for standing by. Once again, I'd like to turn the floor over to Joey Perrone, Senior Vice President and a finance and investor relations.
Please begin.
Speaker Change: Thank you. Hello everyone and good afternoon. Welcome to day one's first quarter financial and operating results conference call. Earlier today we issued a press release which outlines the topics we plan to discuss.
Speaker Change: You can access the press release and the slides to accompany this conference call on the Investors and Media section of our website at www.day1bio.com An audio webcast with the corresponding slides is also available on the website.
Speaker Change: Before we get started, I'd like to remind everyone that some of the statements that we make on this call and the information presented in the slide deck include four looking statements is outlined on slide two.
Speaker Change: Actual events and results could differ materially from those expressed or implied by any foreign looking statements. We encourage you to review the various risks, uncertainties, and other factors included our most recent filings with the SEC and any other future filings that we may make with the SEC.
Speaker Change: These four-looking statements are based on our current estimates and various assumptions and reflect measurements and tensions, beliefs, and expectations about future events, strategies, competition, products, and product candidates, operating plans, and performance.
Speaker Change: You're a caution not to place any undue reliance on these four-looking statements, and except as required by law, they won't disclose any obligation to update such statements.
Speaker Change: Today, I'm joined by Dr. Jeremy Bender, Chief Executive Officer, Lauren Merendino, Chief Commercial Officer, Charles York, Chief Operating, and Financial Officer, and Ellie Berry, Chief Medical Officer. I will now turn the call over to Jeremy.
Jeremy Bender: Thank you, Joey, and good afternoon. I'm excited to share that we achieved another quarter of growth and strong financial performance to start the year. I'm thrilled by the progress we have made thus far in bringing Ojemda to patients in need.
Jeremy Bender: We continue to execute on the three priorities we laid out for our business in 2025 earlier this year. The first is establishing Agenda as the standard of care in second-line plus pediatrically great glioma and driving Agenda revenue growth.
Jeremy Bender: The second is advancing our clinical development pipeline for Firefly 2 and Day 301, and the third is further expanding our portfolio.
Jeremy Bender: In the first quarter of 2025, O'gemda quarterly scripts increased to over 900, representing 16% growth over total scripts in the prior quarter.
Jeremy Bender: This growth drove net product revenue for Agenda to $30.5 million for Q1 2025.
Jeremy Bender: Our consistent growth each quarter since launch and the market dynamics we've observed over the past 12 months have further reinforced that agenda is a foundational opportunity for day one that will drive durable long-term value creation.
Significant untapped potential remains for agenda and relapse refractory PLGG.
Jeremy Bender: Prescriber adoption continues to increase, on-label patient demand has grown steadily, a pair of approval rates are high, and patients continue to experience longer treatment periods on agenda as time progresses.
Jeremy Bender: All of these data points give us confidence that the steady increase in our gender revenue will continue.
Jeremy Bender: Beyond agenda's commercial performance, we remain focused on building value across our pipeline.
Jeremy Bender: We are encouraged by the enrollment progress we've observed in our Global Firefly 2 confirmatory trial.
Jeremy Bender: We expect the trial will be fully enrolled in the first half of 2026 as we endeavor to drive expansion of a gemda beyond the relapse refractory PLGG approval and into the front line PLGG setting.
Jeremy Bender: Additionally, our partner Hipson recently announced that their application for Tobor Affinib was accepted by the EMA for review, bringing it one step closer to patients in that region who remain in need of a new treatment option.
Jeremy Bender: Our Day 301 program also continues to advance through the dose-escalation portion of the Phase Phase 1A trial.
Jeremy Bender: Our successful track record with Ojemda has paved the way for us to continue to discover and develop first in class or best in class programs for both children and adults.
Jeremy Bender: We remain committed to and are actively evaluating business development opportunities that will allow us to expand our multi-program clinical stage portfolio aimed at driving sustained long-term growth.
Jeremy Bender: This is an exciting moment for day one. 2025 is off to a great start. We have a solid financial foundation that provides us with multiple options for value creation in the coming quarters, even during a period when macroeconomic factors present existential challenges and uncertainties for many biotech companies.
Jeremy Bender: O'Genda's launch continues to deliver solid growth, and I am proud of the progress we have established with a clear path for long-term financial and program success for the company.
Jeremy Bender: I'll now turn the call over to Lauren to discuss our commercial progress in greater detail.
Thanks, Jeremy, and good afternoon.
Lauren: Ogenna is off to an excellent start in 2025. As Jeremy mentioned, we delivered $30.5 million in net product revenue in Q1.
Lauren: Our revenue is driven by the over 2,500 total prescriptions written since launch, underscoring both growing physician confidence and the critical role agenda is beginning to play in the treatment landscape of PLGG.
Lauren: This is a substantial foundation of physician experience from which we can grow into your quarters.
Let's take a closer look at our revenue.
Lauren: Q1 marked another quarter of significant growth with our team delivering 11% growth in U.S. net product revenue quarter-over-quarter.
Lauren: We delivered well this quarter, despite some seasonality we observed in January .
Lauren: This was primarily due to the holidays impacting the timing of scans and initiating new treatments which led to a slower start to the year.
Lauren: Since then, we have seen a rebound with April being one of the strongest months for new patient starts since launch.
By line execution continues to deliver a significant impact.
Lauren: Cumulative USO GEMDA prescriptions grew to over 2,500 since launch, delivering 16% growth over the primary quarter.
Lauren: In addition to new patient starts, which we've already discussed, duration is also a key driver of our performance and we continue to see a high percentage of on-label patients continuing on therapy each month.
Lauren: This speaks to the tolerability of Ojenda and the benefit patients and physicians are seeing with our product.
Lauren: Through continuing to expand both breadth and depth of prescribing and supporting physicians and patients during their time on Ojemda, we continue to drive growth in total prescriptions.
Lauren: Artemis Day 1 continues to see and demonstrate a substantial market opportunity for O'Jumda.
Lauren: It can be complex to see the whole picture, so let's break down the growth potential that still lies ahead for our product.
Lauren: This slide summarizes the estimated number of relapsed refractory PLGG patients being managed at each of our priority accounts.
Lauren: We've previously shared our estimate that in the US there is a prevalent pool of approximately 26,000 relapsed or refractory, B-Rap altered, PLGG patients who have received at least one prior treatment.
Lauren: Based on PFS curves, we estimate that about half of these patients are likely in long-term remission and are not likely to need an additional systemic therapy.
Lauren: If we allocate the remaining patients proportionately across our priority groups and divide by the number of accounts in each priority, we calculate the average number of patients managed at each account seen here.
Lauren: This includes both those patients currently on treatment and those who are being monitored for progression and may need treatment in the future.
Lauren: Deft is especially important in our priority one and two accounts who have already gained experience with Ojemida.
Lauren: In these accounts, a substantial opportunity remains to accelerate adoption, drive increased use and establish agenda as the second line standard of care.
Lauren: In priority three accounts, as we would expect, prescribers tend to be more cautious and wait to hear thought leader experiences before trying a new therapy.
Lauren: They also manage fewer patients, so they have less frequent treatment decisions.
Lauren: To get their first patient started, we continue to share the experiences of other physicians and our clinical trial data to help build their confidence in OJMDA.
Lauren: While many accounts are already treating multiple patients with OJMDA, the overall patient volume within these accounts reinforces our strong conviction that significant growth potential remains through deepening penetration and expanding usage across all of our accounts.
To fully unlock a gem this potential, our path forward is clear.
Lauren: First, as we just discussed, our greatest opportunity lies with our current prescribers and increasing the depth of their prescribing.
Lauren: Secondly, we must continue to expand our prescriber base by encouraging non-prescribers to try OJMDA in their first relapsed or refractory PLGG patient.
Lauren: Across our customer base, we must continue reinforcing the value of agenda in the second line setting to drive deeper adoption and to firmly establish it as a new standard of care for these patients.
Lauren: We believe that our soon-to-be released Firefly 1, 2-year follow-up data will further aid in this effort.
Lauren: Finally, with an eye on the horizon, we want to ensure that physicians and patients are receiving the information and support that they need so that they can receive the optimal duration of treatment over time.
Lauren: This includes educating on managing adverse events, dose adjustments, and patient support.
Lauren: Through these areas of focus, we remain confident that we will continue to grow and increase the impact of the agenda.
Lauren: Now, I'll turn it over to Charles for more details on our financial results.
Charles: Good afternoon, everyone. Earlier today, we reported detailed first quarter 2025 financial results in earnings release.
for today's call, I'll touch on a few highlights.
Charles: In the first quarter, US of Gemda revenue was $30.5 million, which grew 11% compared to the fourth quarter, termed by a 16% increase in quarterly scripts.
Charles: Our operating expenses, excluding cost of sales, were $68.9 million in the first quarter of 2025, which included $12.9 million in non-cash stock-based compensation expense.
Charles: In comparison to our fourth quarter of 2024, when excluding the one-time charge of $20 million associated with the in-licens of day 301, we realize approximately 4% quarter over quarter decline in operating expenses.
Charles: By maintaining a disciplined financial strategy as a cornerstone to building long-term, durable growth, we anticipate that cost and operating expenses will remain relatively consistent the rest of the year with some quarter to quarter variability, which allows us to invest strategically in opportunities that support growth while prioritizing our clinical development plan.
Charles: We remain well-positioned financially with a cash balance of $473 million and no debt at the end of the first quarter.
Charles: As we continue to grow, our ability to balance discipline financial management with measured investment is what sets us apart. Based on our current operating plans, we do not project day one will require any additional financing in the future.
Speaker Change: As Jeremy mentioned earlier, our internal expertise in oncology development, registration and commercialization is second to none. With the continued success of the OJM to launch in the disciplined investment approach, we are a well-positioned to deliver long-term, sustainable value.
Speaker Change: Managing our resources responsibly and above all don't be afraid to disrupt the status quo of traditional drug development to get better targeted medicines to patients who urgently need new options with that I'll turn the call over to the operator for Q&A.
Speaker Change: Thank you.
Speaker Change: At this time, we will be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. If at any time you wish to remove your question from the queue. Please press star two.
Speaker Change: Participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys also we remind participants to limit their questions to one with an opportunity to have one follow up.
Speaker Change: Our first question.
Rama: From <unk> Rama with J P. Morgan.
Rama: Hi, guys. This is priyanka on Brian and Paul Congrats on the progress this quarter. Just one question for Mike What are you seeing in terms of duration of therapy in the marketplace and how dogs plan to use the drug long term.
Rama: Okay. Thanks for the question and.
The comments I'll ask Lauren to comment on what we're seeing for duration to date.
Lauren: Yes, so where we're approaching a year on the market. So it is early for us to comment on duration, what I will say is that we continue to see.
Speaker Change: A very high percentage of patients continuing on therapy month after month.
Speaker Change: And the trends are similar to what we would expect considering the.
Speaker Change: The results we saw in the Firefly one study.
Speaker Change: Thank you so much for taking my question.
Speaker Change: Thanks, Patrick.
Speaker Change: Our next question is from Tara Bancroft with TD count.
Tara Bancroft: Hi team. Good afternoon. So I was hoping if you could give us maybe a rough percentage of revenue that's accounted for from new patients versus ongoing patients I know last quarter. You said there were roughly about 280 active patients so getting an idea of that updated.
Tara Bancroft: Number and the relative split would be really helpful. Thanks, so much.
Tara Bancroft: Thanks for the question Terra and what I can tell you is that the dynamics of our new patient starts and our patients on treatment are very similar to what we discussed.
Tara Bancroft: In the quarterly call in February with respect to a couple of elements. The first is the.
Tara Bancroft: The rough percentage of on versus off label remains at.
Tara Bancroft: Plus minus or around 10% off label, 90% on label.
Tara Bancroft: With respect to breakdown of patients we've provided that year end guidance in part because of the start we had with the EAP pool that converted post approval.
Tara Bancroft: On mass.
Tara Bancroft: Going forward, our key metric really will be a total scripts and of course revenues.
Speaker Change: Okay, great. Thank you and just as a follow up any potential color you can give on any any headwinds that you saw in Q1 in particular with regards to like gross to net and reimbursement.
Speaker Change: So let me ask Loren to first comment on <unk>.
Speaker Change: Seasonality, which she mentioned in the script and then Charles can comment on gross to nets.
Loren: Yes. Thank you for the question.
Loren: So we did see some seasonality early in January due primarily to a <unk>.
Loren: Delay in scans and physician appointments.
Loren: Due to the year end holiday. So we saw a slower ramp in January but we have since seen.
Loren: New patient starts rebound and as I mentioned had a very strong.
Loren: Had very strong NPS results in April so.
Loren: That was the seasonality we did see.
Loren: The normal seasonality you see in Q1 is related to payer dynamics in resetting the deductible of course, our patients are subject to that as well. However, the programs that we put in place.
Speaker Change: Did an effective job and Oh really.
Loren: Smooth did that transition for the large majority of patients so.
Loren: So we consider that a success and with that I'll, let Charles comment on gross to net.
Charles: Yes, so from a gross to net perspective, we've previously discussed the fact that.
Charles: We anticipate being in gross to net ranges of approximately 12% to 15% for the first quarter, we remain in that range.
Charles: Much closer towards the higher edge versus Q4 of last year, mostly driven by a couple of realities of our business. The first being that we took a price increase in January of this year, which results in some CPI U.
Speaker Change: Excuse me CPI you penalty associated with it and then as Loren just discussed there was a modest amount of additional.
Speaker Change: Copay assistance required for patients as you would expect in the first quarter of a year did not drive it materially but it does it does impact our number modestly.
Speaker Change: Okay, Great I really appreciate the color. Thanks, so much.
Jeff: Thanks, Jeff.
Alec Stranahan: Our next question is from Alec Stranahan with Bank of America.
Hey, guys, thanks for taking our questions and congrats.
Alec Stranahan: On the progress as well I guess, maybe just double clicking on that prior question, how should we be thinking about new patient starts from here is April trends.
Alec Stranahan: The run rate, we should be thinking about.
Alec Stranahan: For the rest of the year and maybe if you could talk a bit about inventory levels across the various distribution channels or any impacts there.
Alec Stranahan: Maybe benefit.
Alec Stranahan: Second half of last year, and how we should be thinking about that going forward. Thanks.
Speaker Change: Thanks, Alex for the question I'll start on your new patient start topic, and then ask Charles to comment further.
Speaker Change: So what we've seen and expect to see going forward with respect to new patient starts is really what we've been emphasizing since launch and that's a.
Charles: <unk> and steady ramp of new patient starting over time as those patients you know either relapsed or progressed on other therapies in need of new therapy, I would remind you and investors that this is not a typical oncology launch trajectory.
Charles: We really think of this more as a kin to a rare disease launch and that's driven by the relative infrequency of treatment decisions the longer durations of treatment.
Charles: And the disease course for <unk> patients.
Charles: All of that leads to.
Charles: As we've said and we'll continue to see a more gradual adoption and.
Charles: Curve relative to adult oncology lapses, particularly those.
Charles: Those adult oncology launches that occur.
Charles: Ah relapsed or a salvage setting.
Charles: Okay.
Charles: And then as far as.
Charles: Channel stock, how we've looked at it and discussed it previously still consistent from that perspective.
Charles: We from an operational basis.
Charles: We've expressed that to the street.
Charles: Keep our channel stock or attempt to keep our channel stock within a two to four week of days on hand range.
Charles: We do that in order as an internal target to make sure that we have adequate supply for in the channel to meet patient demand, which of course is the main goal there.
Charles: We remain in that two to four weeks there. So we don't believe there is.
Charles: Any really material effect to this current quarter from the channel stock changes itself other than the consistent build you will get as you're increasing sales. So we'll continue to see that as we see growth on a on a specific dollar basis, but will remain within that two to four weeks on hand as much as possible, we step out of that range.
Charles: We'll certainly discuss it with.
Charles: Yourself and other analysts.
Charles: Makes sense thanks for the color.
Alex: Thanks, Alex.
Speaker Change: As a reminder, if you'd like to ask a question. Please press star one. Our next question is from Amit <unk> with Needham <unk> company.
Speaker Change: Hi, This is gonna answer Amit. Thank you for taking my question.
Speaker Change: Could you talk about the penetration that you have within each of the Cherokee Santos.
Speaker Change: What are you doing in order to I guess increase penetration.
Speaker Change: Integration of Golden Doyle concert each side, you said Don Thank you.
Speaker Change: Really great question, Thanks for asking a hand to Lauren, but really do want to reinforce the topic that you just brought up which is that sort of depth of prescribing multiple patients per center is really a key commercial goal for us of course.
Speaker Change: Alright, yeah.
Speaker Change: So when we think of penetration of accounts, we think of both breadth and depth right. So first getting them to try it in one patient and then expanding to more patients. So as we reported last quarter.
Speaker Change: Our priority one accounts, we have 100% of them, who have tried agenda post approval and priority to we have three quarters of them who.
Speaker Change: <unk> tried.
Speaker Change: Under post approval.
Speaker Change: And we've continued to grow that and even an expanded mp3.
Speaker Change: But as Jeremy mentioned now our focus is depth. So once they have tried it now it's about expanding their view of who is appropriate.
Speaker Change: Which patients are appropriate pro gender, so that means expanding their thinking on the location of the tumor.
Speaker Change: Or the.
Speaker Change: The where they are in therapy, and what they've experienced to date, so that element of it and then the second piece, which is even more important is moving up in line. So many physicians try a new product in patients who have received all the other available therapies.
Speaker Change: They're a later line patient and moving and as their confidence builds they will start to use it earlier in therapy and so that's really a focus for us is to drive our confidence.
Jeremy Bender: Confidence it on gender and confidence in using it earlier in that second line and with that Jeremy Yes, I want to add something to the question and that is to really just reinforce what we've discussed in the past with respect to this particular physician community. This is a group that because of the nature of the page.
<unk> and.
Speaker Change: And because of their considerations around sort of long term perspective for treating children are more conservative than the other doctors and for that I'd ask Lee. If you can just comment on what you see.
Jeremy Bender: As a pediatric oncologist.
Lee: Sure. Thanks, Thanks, Jeremy for the question. So yeah. When you think about children with cancer and in particular, a disease like a low grade glioma, where children are expected to live well into adulthood.
Jeremy Bender: When you think about treatment options and <unk>.
Lee: Particular, new treatments.
Of course, you want a drug that networks and reduces tumor size.
Lee: Weighing that against.
Lee: The potential for long term effects and long term toxicities.
Lee: And obviously when you have a new drug on on on the market.
Lee: Program, there's a lot of unknowns when it comes to <unk>.
Lee: And the potential for for any effects.
Lee: 10, 20, plus years down the line.
Lee: Okay.
Lee: Jeremy point around.
Lee: The conservative nature of the physician community.
Lee: It's one of with one important factor that physicians will take into consideration when evaluating new treatments and have a weigh that against.
Lee: Other options are available.
Lee: Yes, and I think that the key.
Lee: Really is that giving those patients as physicians that his deep experience without gender.
Lee: We know it's going to be essential for really getting them comfortable over time and that that's something that is occurring in the market. We're seeing it actively and especially among those investigators who were part of our our Firefly one trial and for the remainder of that will continue but that's critical to that depth point.
Lee: Thanks.
Lee: Thank you.
Speaker Change: Our next question is from Sumit Roy with Jones Research.
Speaker Change: Afternoon, everyone.
Speaker Change: Moving into the development pipeline would love to get some details on the <unk> 301.
Speaker Change: What can you tell us about.
Speaker Change: The.
Speaker Change: It is possible the tumor type dosing was completed what when we should expect the data and how much details.
Speaker Change: Sean Thanks for the question.
Speaker Change: Let me, let me kind of reiterate where we are in and.
Speaker Change: Try to address those elements.
Speaker Change: <unk> hundred one is in a dose escalation in the phase one trial the patients that we're enrolling in those dose cohorts or patients that have specific tumor types that are known to.
Speaker Change: Express at reasonably high levels.
Speaker Change: The target for that for the 301 program the ADC and that target is PTK seven.
Speaker Change: So its endometrial patients.
Speaker Change: Non small cell lung cancer patients triple negative breast cancer patients, there's an array of.
Speaker Change: All adult solid tumors at this point.
Speaker Change: Who were enrolling and we have cleared the first dose cohort as as we articulated in January.
Speaker Change: We are still in the dose escalation phase is we expected to be.
Speaker Change: We have not yet guided on the specific timing of when we'll have data from either dose escalation or potentially dose expansion cohorts available but.
Speaker Change: But I can tell you that the plan is for us to get to those doses that we think are both safe and also in the efficacious range.
Speaker Change: And begin to do two things one is backfill patients into those dose cohorts. So that we get more experience at those particular doses and then too.
Speaker Change: Once we have a body of data that sufficient move to dose expansion cohorts, where we'll narrow to specific histology.
Speaker Change: We haven't really disclosed what those are until we have more clinical experience.
Speaker Change: We'll we'll defer that that disclosure in part for competitive reasons, but the dose expansion will be an important next step and we anticipate that at that point, we'll be employing.
Speaker Change: Diagnostics, such that we can prospectively defined PTK seven expression for the patients who we put into those dose into those dose expansion cohorts.
Speaker Change: Very helpful are you finding.
Speaker Change: The literature.
Speaker Change: And on the PDK expression to be matching up with what youre seeing in the clinic and curious any futility hurdle that you have in mind in terms of safety or efficacy that we decided to go forward in front of them the disclosure of the data.
Speaker Change: Also great questions, it's too early to say whether the.
Speaker Change: Publicly published.
Speaker Change: Data on PTK, seven expression and there's a couple of sources for that.
Speaker Change: Are are going to be consistent with what we see once we're really running trials with our own diagnostic.
Speaker Change: So so.
Speaker Change: Too early to say with any certainty whether that will be the case.
Speaker Change: I think.
Speaker Change: The second part of your question Shannon can you just repeat it.
Speaker Change: I'm trying to understand like what would be the.
Speaker Change: Go forward decision, making point is Oh, yes. Thank you.
Speaker Change: It's going to be a combination of safety and reasonable efficacy.
Speaker Change: So what do I mean by that.
Speaker Change: We need to see in the phase one trial a dose that we think we can move forward into.
Speaker Change: A dose expansion phase end of phase two.
Speaker Change: That is tolerable.
Speaker Change: <unk> has a reasonably competitive profile with other programs that may be in development for the tumors of interest and then we also need to see at least some evidence of antitumor activity.
Speaker Change: And the reason we need we need that that antitumor activity is really just to to have confidence that the exposures that we're seeing at the doses that we think are reasonable and tolerable.
Speaker Change: May result in an efficacy signal that we could then pursue and registration programs.
Speaker Change: Really helpful. Thank you.
Speaker Change: Thanks Shannon.
Speaker Change: Our next question is from Andrea <unk> with Goldman Sachs.
Andrea: Good afternoon, thanks for taking our questions and congratulations on the acceptance of <unk> and Europe.
Speaker Change: On that point I was just curious if you could you.
Speaker Change: If you could talk a little bit more about how you see the market in that geography compared to that of the U S and are there any differences in prescribing behavior and how receptive is the community to all our our data versus outcomes end points like PFS or OS.
Speaker Change: They probably aren't available until firefighter. Thanks, so much.
Speaker Change: Thanks, Andrea Great great questions.
Speaker Change: Let me comment broadly.
Speaker Change: First off.
Speaker Change: The overall market dynamic with respect to patient population.
Speaker Change: In Europe, particularly is fairly similar to the U S. There is no.
Speaker Change: Epidemiological distinction between the rates that you see in European countries versus the U S and so at a high level, you're talking about a similar patient population.
Speaker Change: And.
Speaker Change: There are some differences of course in pricing and reimbursement by country.
Speaker Change: But we think the overall market shape looks quite similar as far as standards of clinical care in Europe. They are broadly fairly similar to what you see in the U S. With the exception that there is.
Speaker Change: <unk> less off label use of products across the board in Europe, and so theres less map kinase or targeted therapy use.
Speaker Change: In general in Europe.
Speaker Change: All of that being said to your question about restaurant response rate as a basis for assessing efficacy that remains in practice, how investigators and doctors, who treat <unk> patients in Europe also think about.
Speaker Change: What they're looking for in a product and so it's broadly pretty similar to what you see in the U S.
Andrea: Thanks Andrea.
Speaker Change: Our next question comes from Andreas Muller Donato with HC Wainwright.
Speaker Change: Hey, guys. Thank you for taking my questions and congrats on the progress two quick questions from us.
Speaker Change: How should we be thinking about Jim Jones positioning on the longer term horizon.
Speaker Change: With respect to Mec inhibitors or other targeted therapies.
Speaker Change: Potentially being used NPL TG across the frontline in refractory setting.
Speaker Change: What are some of the concerns or dynamics. There you can highlight for us and second.
Speaker Change: With a cash position of $473 million.
Speaker Change: Appetite to bring in a new asset or.
Speaker Change: In terms of business development, obviously, we're looking forward to 301 in a couple of other pipeline programs.
Speaker Change: Around color there would be great. Thank you.
Speaker Change: Of course, thanks for the question Andre So let me start with your question about.
Speaker Change: The sort of.
Speaker Change: The market dynamics and usage of targeted agents here in the U S and P. L U D patients.
Speaker Change: Yeah, I'd say broadly speaking.
Speaker Change: There's no clear standard of care in the second line setting for BRAF fusion patients who have P. L. G G and Thats really underpins our our goal of establishing a gender as that as that second line standard of care and.
Speaker Change: The most significant hurdle to getting there is really.
Speaker Change: Just entrenched use and behavior for existing therapies that are used off label, whether those are chemotherapy.
Speaker Change: They can be mec inhibitors.
Speaker Change: There's small numbers of patients who receive other targeted therapies that are not in the map kinase pathway as well.
Speaker Change: And.
Speaker Change: To a significant extent, what we're really looking to do is give physicians an experience.
Speaker Change: That.
Speaker Change: It allows them to understand the product profile here as superior to their experience with those other agents and for all the reasons I've emphasized in the call earlier.
Speaker Change: That is going to take time, but we think theres a real opportunity in particular and that BRAF fusion population to establish that standard of care now.
Speaker Change: I think it's important also to note that in the V 600 segment within P. L. G G.
Speaker Change: There are other approved agents both in the frontline and in the relapsed setting in the map kinase pathway and and for that reason our our focus on on the V. 600 segment is really more on sequencing after use of those agents because those are moving towards.
Speaker Change: Towards the frontline and that would be 600 and as another reminder, the split rough split of patients is 75% to 80% of all <unk> patients are our BRAF fusion patients that's the area, where there aren't any approved agents other than agenda.
Speaker Change: In the relapsed setting and then 15% to 20% of <unk> patients, who have RAF alterations or that'd be six hundreds where you do see Nebraska or interim Aetna as approved agents.
Speaker Change: Great. Thank you very much.
Speaker Change: Sorry, one other.
Charles: Let me ask Charles to comment on business development as well thanks Andres.
Charles: So from a business development perspective.
Charles: What we've talked about previously.
Charles: Okay.
Charles: Business development at day, one is critical to what we believe can generate long term additional growth.
Charles: We continue to have a very active business development process look at a number of different opportunities.
Charles: But also continue to keep a very high bar to what we want to invest in and what we want to put both our capital resources and our human capital to work at.
Charles: So as we continue that evaluation, we will look to find opportunities that we think can continue to grow the business.
Charles: <unk> associated with that is often a challenge to pick this specific time, but when we do see things we will move forward on them.
Charles: An opportunity, but one additional opportunity in our pipeline to be a great start for us.
Charles: And it is something that we'll continue to evaluate over time.
Charles: Thank you ladies and gentlemen, we have reached the end of the question and answer session out of time for today's call.
Charles: Thank you for your time and participation you may disconnect your lines at this time.
Charles: [music].
Charles: Yes.
Charles: [music].