ImmunoGen Inc. Q1 2023 Earnings Call

Speaker 2: Good morning and welcome to Immunogen's first quarter of the 2023 Financial and Operating Results Conference call. Today's conference is being recorded. At this time, I'd like to turn the call over to Annabel Chan, Head of Investor Relations. Please go ahead.

Speaker 3: Good morning, and thank you for joining today's call. Earlier today, we issued a press release that includes a summary of our recent operating progress and first quarter financial results.

Speaker 3: This press release, the recording of this call, and an updated corporate deck can be found under the investors and media section of our website at immunogen.com.

Speaker 3: With me today, our Mark Ennady, our President and CEO , Ganna Berkenblitz, Archie Medical Officer, and Renée Lentiniar in term CFO .

Speaker 3: Michael Vasconcelos, our EDP of Research, Development, and Medical Affairs.

Speaker 3: Isabela Colafonos, our Chief Commercial Officer, and Todd Tallarico, our VP of Market Access, will also join us for Q&A.

Speaker 3: During today's call, we will review recent accomplishments for the business, our financial results, and highlight upcoming anticipated events.

Speaker 3: We will be making forward-looking statements based on our current expectations and beliefs.

Speaker 3: These statements are subject to risks and uncertainties and are actual results made different materially.clock a time, less than a second.

Speaker 3: Please consult the risks outlined in our press release issued this morning, in the risk factor section of our most recent annual report on Form 10-K , and in our other FCC filings, which are available at scc.gov and immunogen.com. And with that, I'll turn the call over to Mark. Thanks Annabelle. Good morning everyone, and thank you for joining us today.

Speaker 4: I'd like to preface this call by saying that the focus of today's discussion will be on Ella Heer's commercial performance and on our ongoing development programs beyond Mirasol. We expect to share top-line Mirasol data within the next couple of weeks, so we'll refrain from commenting on this trial and respectfully ask that you hold any questions.

Speaker 4: We've made a very strong start to 2023, exemplified by the Q1 revenue for Ellihir, the advancement of our clinical programs for four novel ADCs, and the strengthening of our balance sheet by securing a non-diluted credit facility with PharmaCon for up to $175 million.

Speaker 4: Before moving to our launch update, I first want to thank our commercial and medical teams for their outstanding work bringing Ellahear to market. In particular, I'd like to recognize Todd Tallarico, who has served as our interim chief commercial officer over the last five months for the exemplary performance leading the initial stages of the Ellahear launch.

Speaker 5: Todd, thank you.

Speaker 4: I would also like to welcome Isabel Califanos, who joined us on Monday to drive the continued success of Ella here leading our high performing commercial organization.

Speaker 4: On that note, building on a fast start to close 2022, our teams made notable progress across all four launch imperatives as we worked to position Ella here as the standard of care for folate receptor alpha-positive ovarian cancer. In the first full quarter since launch, we generated $29.5 million in net.

Speaker 4: We saw a significant percentage of accounts with repeat orders complementing new patient starts. While academic institutions comprise our largest customers, roughly 70% of orders during the quarter continued to come from non-academic institutions and community-based oncology groups, and 80% of orders from new accounts came from those with no prior experience with

Speaker 6: in-house.

Speaker 4: We estimate that roughly 5,400 full R1 tests were performed during the first quarter and that a significant percentage of these tests are for newly diagnosed patients.

Speaker 4: In addition, our data indicates that the full late receptor alpha positivity rate was between 35 and 40 percent, which is in line with our clinical trial experience. Regarding access, we are very pleased with how quickly payers have included Ella here and coverage policies aligned to our label. We entered the quarter with 55 percent of Medicare and 70 percent of commercial

Speaker 4: on target accounts, particularly in the community setting. To complement these efforts, our medical affairs team has been highly engaged in providing a full suite of support services to ensure a positive start and continuation of therapy by our patients and their physicians. Reports from the field continuously relate enthusiastic feedback from clinicians regarding

Speaker 4: is driving adoption, adherence, and the pace of growth, including more false and claims and other data with respect to FR alpha testing rates and the mix of testing at initial diagnosis versus testing to initiate treatment, monitor therapy versus combination use, moving from prevalent to incident populations and duration of therapy and discontinuations.

Speaker 4: So with that, I'll turn the call over to Anna to provide additional color on ongoing development programs. Anna.

Speaker 3: Thanks Mark. We were pleased to present additional data from the Saraya trial at SGO last month, highlighting the final median overall survival of 15 months, with 37% of patients alive at 24 months, as well as the anti-tumor activity of Mervatuximant across different subgroups.

Speaker 7: We were also excited to receive resoundingly positive physician feedback on Ella here at the conference. We are very proud of the work our medical affairs team has done in this area.

Speaker 7: Let me now turn to the broader Mervatuxinab development program, which has the potential to meaningfully expand to the L-Agear label. In January , we completed enrollment in Piccolo, our single-arm trial of Mervatuxinab monotherapy and recurrent platinum-sensitive ovarian cancer patients with high FR-Alpha expression.

Speaker 7: and we anticipate a readout on the primary endpoint of ORR before the end of this year.

Speaker 7: As we look to position Mervatoxamab as the combination agents of choice in ovarian cancer, we are progressing two studies. The first is our phase 3-Loriosa trial, evaluating Mervatoxamab plus emphasis in that maintenance versus standard of care-bethuses in that maintenance in the second line platinum sensitive setting. The second is trial 420.

Speaker 7: A single-armed phase two study evaluating merved plus carboplatin followed by merved continuation in platinum sensitive ovarian cancer patients with low medium or high level defolate receptor alpha expression.

Speaker 7: Both trials are up and running in the US, and we are working on opening them in Europe as well.

Speaker 7: Moving to the rest of our pipeline, we remain on track to complete enrollment in our pivotal CADENZA trial of PVET in frontline BPDCM this year and anticipate top-line data in 2024.

Speaker 7: As a reminder, last year we aligned with FDA that the efficacy of valuable population will be in front line the NOVO BPDCN patients, and we also are continuing to enroll patients with a prior or concomitant hematologic malignancy to further explore the potential benefit of PVEC in this population. For our AML program, we progressed our 802...

Speaker 7: and guide pivotal development in frontline AML.

Speaker 7: We look forward to reporting data from these frontline cohorts later this year.

Speaker 7: In addition, in collaboration with Gilead, we are preparing to initiate a separate cohort in relapse through a fraftary CD-123 positive AML to evaluate the safety and efficacy of a novel P-Vest Negrotlamab Dublet in the second half of the year.

Speaker 7: As for our earlier stage assets on IMGC936, our first in class Adam 9 targeting ADC in co-development with macrugemics, we have completed dose escalation without reaching an NTD and selected a recommended phase 2000 schedule of 6 milligrams per kilogram every three weeks.

Speaker 8: analysis is completed.

Speaker 7: Lastly, we commit patient dosing in our phase one trial of IMGN151 earlier this year, and we are continuing dose escalation. This trial is designed to address a broader range of folate receptor alfets, breast and tumors, with initial exploration in ovarian and endometrial cancers. So as you can see, we're off to a great start in 2023 and look forward to advancing our pipeline.

Speaker 3: million dollars of license and milestone fees and the remainder from non-cache royalty revenues and R&D support fees.

Speaker 3: Operating expenses were $91.6 million, comprised of $51.6 million of R&D expense, and $40 million of SG&A expenses.

Speaker 3: We ended the first quarter with $200 to $1.2 million in cash on the balance sheet. And in early April added $75 million with the drawdown of the initial tranche of the terminal facility with Pharmacon.

Speaker 3: and $50 million, and operating expenses between $320 million and $335 million. We expect to provide Ella Hair Product Revenue Guidance later this year.

Speaker 3: The increase in our revenue guidance is a result of recognizing a $15 million up front fee in the first quarter related to our license and option agreement with Burf Tech. As no deferral was required.

Speaker 3: Additionally, the company increased its operating expense guidance to reflect greater spend in support of Ella here's current success and expected growth trajectory.

Speaker 3: We expect that our current cash, inclusive of the $75 million received pursuant to the terminal and facility with pharmacons, and combined with anticipated product and collaboration revenues, will fund operations into 2025.

Speaker 2: But that will open the call for questions. If you'd like to ask a question, please press star 11. If your question has been answered and you'd like to remove yourself from the queue, please press star 11 again.

Speaker 2: Our first question comes from John Newman with Canacor Genuity. Your line is open.

Speaker 4: Hi guys, good morning. Thank you for taking my question. Just had two quick questions. First one is regarding top line data for Mirisol. Should we still expect a focus to be on PFS with some discussion of immature overall survival data? Second question, I'm Ella here. Obviously, you are only promoting for the labeled indications, but curious if you can talk at all.

Speaker 7: it will be mature enough for the regulators to review.

Speaker 9: Right, in terms of the market uptake, John , this will be a little bit of a recurring theme on this call, which is we've got very limited data at this point. We have claims data for less than 100 patients. And so it's difficult to sort of articulate any conviction around trends and so on. What I will say.

Speaker 2: Thank you. Our next question comes from Michael Schmidt with Guggenheim Partners. Your line is open.

Speaker 4: Hey guys, good morning. Thanks for taking my questions and you got to come and I'm glad for this very impressive first quarter of solid.

Speaker 4: How, what are you seeing right now in terms of, you know, repeat customers, repeat patients versus new patients starting on therapy in the first quarter. And do you have an early read on duration, realizing that it's only been a few months at this point?

Speaker 9: Yeah, so obviously we do see a significant percentage of repeat orders coming from the accounts. Again, as I say, it's a little bit, we're just four months in and as I said, we've got 100 patients with acclaimed data. So, you know, what we can see are the accounts that are ordering.

Speaker 9: have a very healthy percentage of new counts coming online and a significant percentage of repeat orders, but it's hard to sort of take that down to the patient level. So again, no strong sense at this point in terms of duration of therapy.

Speaker 4: Okay, and then just thinking about the trajectory over the rest of the years and one key was obviously about our expectation. And you know, anything node worth for you as we, you know, head into early, you know, April , you know, data.

Speaker 10: I think you mentioned through a prevalence versus incidence shifts perhaps, you know, anything, you know, no worthy exit pertains just over the...

Speaker 10: the size of the address or population or any other market dynamics as we think about the trajectory of the rest of the year.

Speaker 9: Yeah, so maybe a few high-level comments here. You know, as we see the data emerging and assess the performance, the execution here, the strength of the launch is really being driven by floor factors. The first is unmet need. You know.

Speaker 9: bears repeating that this is the first new drug specifically approved for platinum-resistant ovarian cancer in almost a decade. Seventy-five percent of these patients receive single-agent chemotherapy, which is characterized by low overall response rates, with short duration and significant side effects, which really leads us to the second part of the question.

Speaker 9: both in terms of our physicians and patients who recognize the benefit that that profile confers for this population and the innovation that we're bringing to the space.

Speaker 9: Equally important, this is a physician population that is acclimated to testing. So between bracken mutation testing and HRD testing, this is a prescribed base that's accustomed to ordering tests for their patients. And so we see that.

Speaker 9: with the uptake and testing, which continues to be very robust. And then finally, one of the questions going into this launch.

Speaker 9: was how are you going to manage the baseline ocular screening and happily tip that precede us by a pretty good margin going into this market. So again, what we find across the prescriber base is that physicians already have established referral bases.

Speaker 9: were ocular exams and so we've been able to ride on the back of that and so with those factors in mind our team has done an excellent job executing both prior to approval as it relates to education of the market and then post approval.

Speaker 9: And really becoming and establishing ourselves as a value partner to the ovarian cancer community. And you know what that has translated into is strong demand for testing, broad and deep adoption. You heard us talk about the uptake in the community and particular positions with no prior experience with the drug.

Speaker 9: inventory in the in the channel. We have one specialty firm set up for those who are, you know, not wanting to

Speaker 9: the buying bill, but it's a nominal amount of files there. So as we look ahead, obviously, the revenue in this quarter was 10x what it was last quarter. And I think it's safe to say that that will not continue to scale linearly.

Speaker 9: That said, we just have a lot to learn about this market. And we think that the pace of growth here is going to be driven by a couple of key factors. The first is testing rates and the mix of patients being tested in particular, whether they're newly diagnosed patients or for patients that are...

Speaker 9: So it's something that requires additional data to sort through. Secondly, monitor B versus combination therapy. Combo patients tend to respond at higher rates and stay on therapy longer. But as I say, the claims data that we have available is limited.

moving from the prevalent to the incident population. So this gets a little bit complicated, Michael. But when you look at ovarian cancer overall, the prevalence is over 230,000 women living with ovarian cancer in the US.

to assess the split between platinum resistant and platinum sensitive and also...

other parameters. But when you add up the newly diagnosed patients in first line through six-blind, irrespective of whether it's platinum, sensitive, or platinum resistant, that's 54,000 patients each year. So you see the difference between this prevalent population and the annual incidence.

population. And so, you know, while using annual incidence, we think it's a better approach to modeling and advanced cancer population, particularly before Ellie here with a median overall survival of less than a year. It really doesn't account for launching into this prevalent population with limited treatment options. So, the prevalent population is larger, but we have no-

That's a really long answer to your question, but that's the best of what we have right now.

All right, thanks for all the detail, Martin. Thank you. Our next question comes from Ed Sir Daroud with BMO. Your line is open.

Great. Thanks for taking questions and congrats on a strong quarter here. I just, maybe if you could comment at all on sort of what you're seeing sort of exiting April versus sort of the first three months of the year kind of realized it's early just wanted to kind of understand maybe some of the momentum exiting the first quarter and he now.

We see continued momentum and continued growth of the product in April , but we're going to stay away from that. We're going to report our numbers on a quarterly basis in regular order to avoid a ton of this kind of conversation.

got it. And then maybe if you could give a little bit of feedback on sort of how physicians are testing and maybe the results that they're getting for sort of testing of a fully receptive alpha and newly diagnosed ovarian cancer patients, just sort of curious.

sort of, you know, the testing is sort of how they may or may not sort of use those results.

you know, the testing is sort of how they may or may not sort of use those results.

Yeah, the testing up to this point has been very robust. As Mark mentioned, we've had over 5400 tests this quarter. What we're seeing in the area in the community and the physician population is that they're moving more from...

you know, a treatable patient and into the patient population where a newly diagnosed very impatient.

Each of those centers are uniquely different, but we're also seeing a lot of certification of labs in those markets at this point. So Mark mentioned testing has been very well received. Physicians are quickly acclimating to it and we've seen very little pushback on the testing requirements.

If that was your question, wasn't it after or?

Yeah, just want to curious around sort of the, you know, testing of newly diagnosed patients, versus sort of, you know, testing and kind of the platinum resistant ovarian cancer population and sort of maybe the reasons or the dynamics why those physicians are running the test.

Yeah, sure, that's a high. So, you know, when physicians initially diagnose the patient, most patients do get initial debulking surgery. That's when they have tumor tissue sent to the lab. They're already planning to check for BRCA mutations in the tumor. They're also already planning to check for homologous recombination deficiencies.

the treatment option for them.

Got it. Thank you. Thank you. Our next question comes from Andy Saag with William Blair. Your line is open.

Well, congratulations to everyone at the Immunigen for the spectacular Ella Hair Launch. I've answered questions pertaining to the...

to continue to the commercial launch. So first is, do you have a sense of the magnitude of Ella here penetration both in the labeled population and also in the compendial listed population? Secondly, from a physician feedback perspective, just wanted to dig a little bit deeper. And then, we acquire the excitment of the ??????? tested graph. The level synchronization carries ??? the actual core-ons ???ot 354 verm and 27 leverage zero

into what is driving the uptake? Do they tell you about, you know, maybe longer, more deeper disease control, tolerability, and is there a difference within the academic or a community settings?

Well, on the first question, it's really too early for us because our claims data is not robust enough or mature enough for us to triangulate the data to provide you the understanding of the patient population, whether it's...

against the NCCN 2A or 2B positioning. So, too early for us to provide that.

Yeah, you might want to answer that out. And then in terms of what's driving the updates, let me just build on what Mark said initially around the unmet need here and what physicians expect with available therapies versus what they know about Ella here based on our clinical trial data. You know patients with platinum resistant ovarian cancer, their median overall survival is about a year.

plus or minus a month or two. And with available therapies, single agent chemotherapies give you a response rate, you know, in the around 10 percent range. So physicians, when they're taking care of these patients, they're not really expecting responses. They're hoping for stable disease. And they want to give their patients drugs that are well tolerated. And you know, by the...

And also the duration of our response, this is quite long, you know, approaching seven months. And so in that context, then they talk about the tolerability profile and patients really like the fact that you don't lose your hair with Ella here. And it's a convenient, once every three weeks schedule, as opposed to, you know, weekly or daily times five. So I think it's really highlighting the unmet need and the fact that there's been nothing approved.

in the space for about 10 years. So I think that's really what we're seeing. And if you engage with physicians who take care of these patients, that's what you'll need for them.

Great. Thank you. Anna, can you do you mind talking about the interim analysis for IMDC 936 just in terms of what that entails? Thank you.

Yeah, sure Andy. So it's a standard Simon II stage design. We have an initial stage and once we're done enrolling those patients, we would then continue enrolling to have a larger single arm cohort of patients. And so, yeah, after we've passed that intern analysis, we'll share data.

Thank you. Thank you. Our next question comes from Boris Peeker with Cohen. Your line is open.

Great. Thank you. Let me add my congratulations on excellent results. I guess at first I just want to probe a little more on the testing. And so I'm going to confirm, are you still paying for all the fully-recipated alpha testing? And do you have a quantitative sense of what fraction of the testing specifically being in patients that are eligible for Ella here versus others that are earlier on and are not immediately eligible for Ella here?

Yeah, so we do pay for a significant percentage of the tests today, those that are performed at what we call the TARF labs. Those were the centralized labs that we set up at just prior to launch. As we mentioned on this call, a number of these tests are being taken in half.

test as well. But again, this is roughly $300 for us. So when we think about the investment here and lowering the barriers to prescribing, we think this is an important element of the story. And as I said, we have a prescriber base here who is very accustomed to ordering tests for their patients in the first instance.

As before, we do not have any sense of how many of these tests are being performed for newly diagnosed patients versus those who are ready to initiate therapy. It's just a tricky analysis to look at.

folks that are ordering the tests versus the accounts that are ordering drug, you know, in an inability to match positions and so on. So we just don't have that visibility at this time. Got it. I think, Washington, is on the vision toxicity, are you collecting any data that you could kind of get a better sense of exactly.

how this is playing out in the real world, you know, what the dropout or this continuation rate is or any other kind of observation about managing the side effects. So, you know, we've done a really nice job building on that what TIFFDAC started in terms of connecting oncologists with I care.

the real world as it is. So I think that really emphasizes the importance of our medical affairs team going out there and engaging with physicians and understanding what they're experiencing. We have sort of a continuous quality improvement effort, if you will, and as we're hearing feedback, we're adjusting how we're engaging with sites to make sure they have the information.

Thank you very much for thinking my question. Congratulations again.

Thank you.

Thank you. Our next question comes from Peter Lawson with Barclays. Your line is open.

Great, thanks so much, chef, off my regrets as well on a meaningful revenue. And just feeling off the last...

question, what's been the feedback from physicians around ocular toxicity?

So the feedback really has been that the materials that we've provided them have been incredibly helpful so that they know what to expect and how to counsel their patients. And we're patient-facing materials. We have materials for oncologists and for eye care professionals.

Yeah, it's been, this is Mike, it's been a really nice partnership to work within the eye care professional community and create the partnerships with the treating physicians. And as Anna said, it's.

Yeah, I mean, just keep in mind that we have on staff to op theologist working here at a munigen. And so as Mike was alluding to, when we get noticed that an account has ordered, we dispatch the team to educate on the on the on the ocular management and if need be provided.

Perfect and then just if you can make any comments around the...

revenues performance, like a month by month in one queue and then

Whether these patients you think are kind of early line or late line just that would be great to get some details around where those patients are in the journey.

Yeah, so we're going to stay away from monthly revenue. You will appreciate that it's growing and continues to grow. And then, sorry, Peter, your second question, what's that? Yeah, as I say, we've got less than 100 patients worth of claims data at this point.

Peter and so you know I think it's hard to match that against the totality, the experience that we have at this point to give any sort of definitive guidance. Obviously there are some early trends but we would much prefer to have this product in the market at least six months before we start you know sort of parsing the data.

Yeah, I don't think their approach in this is salvage therapy. I think that what they're looking for are patients who are FR alpha positive and looking at what the choices they have for one of those patients. And I think when you've got an FR alpha patient, they're looking to put the patient on drug irrespective of their line of therapy. And you know the...

NCCN guidelines were helpful in this regard in terms of not confining the recommended use of the drug by line of therapy. So that's militated in both directions in terms of later line patients but also earlier line patients.

Great, thanks so much. Thank you. Our next question comes from Kelly Shee with Jeffries. Your line is open.

I can write down the style of Q1. The volume under community here was this academic center was mentioned as table at a 17-13 versus Q4. I'm sure if this is a 17-30 is also the spirit of patients taking full treatment at a community center versus academic.

the mix from community to academic. Okay.

Yeah, so the, okay, you know, right now I think the community has come in stronger than we anticipated. And I think the academics are growing. So we're starting to see the academic centers start to carry higher volume across our customer base. That's those who I met for any understanding thru, this has arrived and thank you donate it better the

We have roughly about 400 accounts that are currently ordering. But the academics have taken a little longer, I think mainly because we've seen P&T reviews, formulary placement, the development of order sets, EMRs. There's been a number of things in the ocular management protocols to be put in place.

Can't really say that there's been a real trend directionally that community will be the key driver, but I think that mix will shift over time. And then to your second question, Kelly, regarding IMGC936, we will share data once we have passed the interim analysis.

Hi, good morning, guys, and I'm also going to offer my congratulations on a very well-executed first quarter sales here for Ella here. So, Anna, we've spoken in the past a little bit about this, but I just wanted to check back with you and see that as you're getting more patients, what are you seeing in the – excuse me, I've got a frog in my throat here – what are you seeing in terms of the resistance mechanisms to Ella here that are emerging? I understand it's early days, but we might just be in a position to maybe give us more color on that. And then also – I just wanted to–

in the commercial uppicks out of the Ella here. Just wondering if it can provide us any color on the uppick among medical oncologists versus guidance. Thanks guys. Yeah, so we're certainly interested in mechanisms of resistance to Ella here. Ella here has a tubulin directed payload. The data that we've generated were a few years ago.

no rapid downregulation of folate receptor alpha. We did have an optional biopsy at the time of progression. As you can imagine, most patients when they're being told the drug is no longer working for them are a little less interested in subjecting themselves to a biopsy. So I think, you know, as we manage the life cycle of Ella here, we will continue to learn.

from a scientific perspective to better understand what mechanisms of resistance may occur. That being said, the duration of therapy that we are seeing overall and particularly in the patients with a confirmed response really suggests a meaningful benefit to patients. Thank you.

And if I jump in on the question specifically around the med arm to dine arm community.

At this particular point, the majority of our tier one physicians that we launched into were primarily gynecologic oncologists. We've had strong interest in feedback in that community. We've had about 81 percent.

Those customers have been seen by our field reps and overall we've had over 900 customer interactions with face to face or presentations. But some of those are a combination of metalk and gyna. The medical community really actually manages the disease over time. So we do see some...

GynoX will probably actually work with the patient and transition them over. And again, I think the community positioning, you'll see more medical oncologists treating these patients based on their comfort level with the product over time.

Thank you. Our next question comes from Joe Kattenzerra with Piper Sandler. Your line is open.

Hey guys, thanks so much for taking my questions and my congrats on the really nice quarter here. Maybe first question, and I hate to ask it because I think Mark you said you wouldn't provide any details on this. But when you look at repeat orders and the timing and number of vials requested, does that provide any early insights into extent of those interruptions or reductions? Maybe you could say whether that's tracking in line with clinical experience or not. And then...

On the ADAM9 program, I think I recall you had previously guided towards initial expansion data including both lung cancer and triple negative, but it sounds like we'll now just see lung. So, I'm wondering if you could just speak to your updated thinking on TNBC. Thanks. Yeah. So, what we see on a daily basis is the orders that are coming in, and we can assess that again, so which of those are new accounts and which are...

But just to be clear, the uptake there is ahead of our expectations and they are in fact our largest customers. But it's hard in that context to tell whether you've got a new patient from one of these larger accounts or whether you've got a repeat patient. And so...

And then, you know, separately, you know, at some point we will see accounts not ordering. And after a certain period of time, I think you can assume that you've had a discontinuation there. But again, given, you know, that these data are being reported to us from a claim space crisis.

with a 60 to 90 day delay, it's really hard to get at the discontinuation rate. And again, in the larger accounts, it's going to be confounded by multiple patients. And so that's where we are today. Obviously, as we accumulate more experience, we'll have a better sense of those things. And switching back to your second question about

stage of the Simon II stage design.

to stage design. OK, got it. Thanks so much.

Thank you. And our last question comes from Jonathan Chang with SBB Securities. Your line is open.

Hi guys, thanks for taking our questions. This is Vascoa Lone for Jonathan and congrats on the progress this quarter. I just wanted to ask that you revised the OpEx guidance up a little bit. Could you describe what are the drivers going into that?

Sure. We obviously are looking as it relates to OPEX.

We've seen with Alejaren's in support of the growth trajectory and the success we are spending more than expected.

And we reflected that in the guidance for the year. Got it. Okay. And then on the PICLO study, could you guys discuss what's the regulatory bar for indication expansion in that setting?

Yeah, so pick a lowlyizar monopherabine, Mervatuxinab trial, in later line platinum sensitive disease. The regulatory bar there, I would say, is evolving in the sense that there are more and more later line platinum sensitive patients now with really widespread adoption of part maintenance.

in the front line and sometimes in the recurrent platinum sensitive setting, which is essentially artificially extended to platinum-free interval. We know these patients, unfortunately, have cross-resistance to these agents that damage DNA. So even, you know, after you've had a PARP inhibitor, more and more data are coming out that even though you technically are platinum sensitive, based on the...

time from last dose of platinum. Your tumor is not as sensitive to platinum-based chemotherapy as it would have been in the pre-park days. So that actually is impacting what our thoughts are around expectations for available therapy. And in fact, it may be that these patients will do worse than they would have, again, in the pre-park era. You know, we're working to assemble the data that are emerging.

to help establish what that benchmark could be. I would anticipate we would need to get very solid alignment with FDA on what that benchmark would be for us to proceed with a single-arm study for accelerated approval. And I would say that is still evolving.

Thank you for taking another question. Thank you. We have a follow-up question from Peter Lawson with Barclays. Your line is open.

Right, thank you so much. Thanks for the follow-up. If you could remind us again about the studies that you could use as a confirmatory study beyond Marisol and if the FDA, if you spoke to the FDA about those studies. Sure, so if...

needed, glorial potentially could support, could become the confirmatory study. And the reason I say that is it is up and running. We have discussed the design with FDA and it's a randomized phase three study in a different setting in the recurrent plant and a sensitive maintenance setting.

So, certainly it could serve as a confirmatory study. However, we have not engaged with FDA on that potential. It's really not a good idea to engage in what if conversations with FDA. And so at this point, our focus is on Mirafal data. Early May.

So you'll be well positioned to start those conversations if needed with the pluralism.

Yes. Thanks so much. Thanks for the follow-up. Thank you. There are no further questions. I'd like to turn the call back over to Mark Entity for any closing remarks. Great. Well, thank you all for joining us again today. We are very pleased with the start we've made with Ella here and the—

partnership that we're building with the ovarian cancer community, and we look forward to speaking with you soon to provide the results from the MIRASOL study. Thanks.

Thank you for participating in today's program. This does include the program and you may now disconnect. Everyone have a great day.