ImmunoGen, Inc. Price & Performance (IMGN)

With that, I'll turn the call over to Mark. Thanks, Annabelle. Good morning, everyone, and thank you for joining us today.

Has been another productive quarter for ImmunoGen, highlighted by the ongoing exemplary execution of the commercial launch for Elihir in the U. S. Progress made towards both geographic and label expansion for Elihir and the advancement of our portfolio. Starting with the commercial update, we delivered a strong quarter with Elijir generating just over $105,000,000 in net sales resulting in over $210,000,000 in revenue year to date, which puts us on track for one of the most successful oncology launches In a decade. This performance is driven by a combination of factors, including strong adoption of FR Alpha testing, and corresponding product ordering in a population with high unmet need with robust uptake in our labeled indication across both academic and community settings, as well as discretionary use in a broader patient population based on NCC guidelines including use of Elijir monotherapy in later lines and in combination with Bevacizumab. Rapid achievement of broad access and reimbursement, increased breadth and depth of prescribing, driven in part by penetration into priority accounts and increased awareness of Elohir driven by engagement by our medical affairs [indiscernible] The compelling data from Mirasol and positive physician and patient experience. [indiscernible] Looking forward, we expect continued growth, albeit at a moderating pace supported by continued focus on execution with respect to our launch imperatives, a strong and growing prescriber base and ALHERE becoming the medicine of choice for patients with FR alpha positive disease.

Isabel will have more to say about our current and future business in a moment. As we aim to expand the geographic footprint for Elihir, and look to bring this novel ADC to patients globally, we are pleased to share that the EMA has accepted our marketing application to support potential European approval and our partner, Huazeng, received acceptance of the NDA in China. In addition, we announced the collaboration with Takeda to develop and commercialize Elihir in Japan and submitted a supplemental BLA to FDA so to to full approval here in the U. S.

In step with our commercial efforts, we are advancing the broader Elijir development program to support label expansion into platinum sensitive disease and to position Elahi here as the combination agent of choice in ovarian cancer. In this context, we are pleased to share that our Piccolo Phase II trial evaluating Elihir monotherapy in platinum sensitive ovarian cancer has met its primary endpoint of objective response rate. Noting that Piccolo is ongoing and patients are continuing to receive LAHERE, to date, we've observed no new safety signals in this patient population. Data represent an important step towards expanding Elihir in the platinum sensitive setting and Mike will discuss these data in more detail shortly. Turning briefly to the rest of the pipeline. In our 2nd pivotal program, feedback, we look forward to reporting data from our PVAC triplet and frontline AML later this year at ASH, and we are on track with top line data from the pivotal frontline de novo cohort in BPDCN 2024. In addition, IMGC 936 and IMGN 151 are progressing remain focused on reinvesting in our research capabilities and expanding our pipeline. Lastly, I'm pleased to report that we strengthened our leadership team with the recent appointment of Lauren White as Chief Financial Officer and commensurate with our expanding commitment to continued innovation of our ADC platform we welcome Heather Hewitt as Chief Scientific Officer.

With an experienced management team in place and a strong balance sheet, are well positioned to expand the commercial opportunity for Eluhir and in parallel continuing to advance and invest in our pipeline. With that, I'll turn the call over to Isabel to cover our commercial progress. Isabelle.

Thank you, Mark.

The commercial team built upon the strong momentum established in the first half of the year and delivered another strong quarter as we continue to make progress towards [indiscernible] Ella here as the standard of care portfolio receptor alpha positive ovarian cancer. In the Q3, saw a 35% sequential growth versus the prior quarter. We are pleased with our performance since launch and believe it is due to a combination of 4 key factors, including: strong adoption in an area of high unmet need, rapid access and reimbursement coverage, the solid execution of our commercial customer facing team, and increased physician experience and awareness of the benefits this novel treatment brings to patients with advanced ovarian cancer. Let me take some time to address each of these key factors in more detail. [indiscernible] let me share some insights into Dynamics Observe while launching into an area of high unmet need.

Starting with the identification of eligible patients, almost a year into our launch, we have seen the overall awareness for referral for testing increase. And rapid adoption of the FOLIAD one diagnostic being incorporated as a standard component of the initial panel conducted on newly diagnosed patients and for patients moving to the next line of therapy. Our market research indicates that over 80% of physicians are familiar with FR alpha testing. Up from a baseline of under 50% at the time of approval.

It is becoming the standard of care that will enable oncologists to rapidly incorporate Ella here into the treatment decision. Needless to say, testing has not been a barrier to adoption. Since launch, we have endeavored to provide the market with the number of tests conducted at our 3 largest centralized labs. As of the end of the quarter, that number stood at roughly 16,000 tests. However, approximately 40 labs now certified to run the test, our visibility into the number of tests performed has decreased and will discontinue reporting on this metric on subsequent calls.

We will, however, continue to report the foliar receptor alpha positive rate which remains between 35 and 40% in line with our expectations. Looking at patient adoption, ELLA here addresses a high unmet need among platinum resistant ovarian cancer patients, As indicated by the initial strong uptake in later lines, where the yield has been great.

In the Q1, the vast majority of patients were from later lines of And as the launch has progressed, we'll set a shift to earlier lines. This is slow and steady trend and we expect this to become a key driver of future growth. Moving to our 2nd key factor, access and reinvestment. [indiscernible] we secured coverage policies aligned to our label for over 90 5% of both Medicare and commercial life. Within the 1st 7 months of launch. Exceeding another benchmark. [indiscernible] NCCN guidelines, we have seen utilization in a broad population including the use of monotherapy in later lines and in combination [indiscernible] in low, medium, and high FR alpha expression patients. 3rd, strong execution by our Our customer facing 15 has been highly active since launch. During the Q3, they continued to engage priority targets [indiscernible] resulting in continued growth in both academic and community accounts. Complementing your account generation, a significant percentage of accounts with repeat orders. While academic institutions continue to comprise our largest customers, roughly 70% of orders during the quarter, came from non academic institutions and community based on quality group. Consistent with the prior And lastly, increased decision experience and awareness. We place a high priority on increasing awareness and cultivating a positive physician and patient experience.

Based on our market research, 5th in August with over 120 physicians across the academic and community settings, over 80% of physicians are aware of Elahir. This has nearly doubled since April and we are especially pleased to see awareness increasing with medical coaches. We attribute this to the compelling data from Mirasoro to the robust engagement by our medical affairs team. Who has continued to provide a full suite of support to ensure positive physician and patient experience. As a testament to their efforts, reports from the field consistently relate into CRT's feedback from clinicians regarding their experience with Elahir. In summary, we are very pleased with our performance today And based on the market research, just referenced, expect continued growth fueled primarily by Number 1. [indiscernible] Awareness of FFR alpha testing as a biomarker is already high, and physicians indicate a 30% growth with the convenience of in house testing and testing earlier in the patient journey. 2 increasing awareness of the benefits ELYA here brings to patients with advanced ovarian cancer. As physicians gain experience and our medical affairs team continues to educate on our clinical data in both monotherapy and in combination Our research shows that physician education translate into increased depth and breadth of prescribing with current prescribers projecting higher rates of utilization in both monotherapy and combination.

Also, we anticipate physicians previously unaware becoming new adopters. We also expect to see increasing treatment rates over historical benchmarks given the compelling efficacy of LRH and increased experience with the treatment. Including the management of adverse events. 4, signs of therapy. Improving perceptions relative to the standard of care will support moving into early lines of therapy or treatment in the platinum resistant setting. Finally, we are also currently filling a demand study and we expect to gain additional insight into the current and future utilization of Elahir. With that, I would like to turn the call over to Mike to provide additional color on the Elahir development program and our broader pipeline. Mike Thanks, Isabelle. We were pleased to present additional data from Mirasol, our randomized Phase III trial of Elohir in platinum resistant ovarian At the 24th Annual European Society of Gynecologic Oncology Congress, in September. [indiscernible] professor of gynecologic oncology at the University of Luban, presented 2 subset analyses in an oral session. Highlighting efficacy benefits with AlloHERE versus investigator choice or IC chemotherapy in progression free survival, objective response rate and overall survival. Doctor. Benghorpe reported on subsets defined by the number of prior lines of therapy Or prior PARP inhibitor exposure.

With no new safety signals arising from these analyses, these findings provide valuable insights [indiscernible] Into Alahir's consistent clinical benefit compared to IC chemotherapy in both subset. Turning now to the broader Mirvetuximab clinical development program, we aim to expand the AlloHear label into platinum sensitive ovarian cancer and further position AlloHERE as the standard of care in fully receptor alpha positive disease.

We are currently advancing 3 sponsored clinical trials in support of these objectives.

Let's start with Piccolo, our single arm Phase II trial evaluating Mirvetuximab monotherapy efficacy and safety in patients with FR alpahi platinum sensitive ovarian cancer who have received at least 2 prior lines of platinum containing therapy or have a documented platinum allergy.

The unmet medical need in this patient population is noteworthy and growing driven predominantly by 2 key factors.

First, Even if a patient meets the clinical criteria of platinum sensitive disease, each subsequent line of platinum containing therapy is associated with both decreased efficacy That's measured by a lower probability of achieving an objective meaningful response duration, and decreased tolerability With this reality, available therapy for these patients today is limited.

Second, emerging clinical data indicate that treatment with a PARP inhibitor may negatively impact the efficacy of such platinum containing therapy.

Given the importance of PARP inhibitors in the maintenance setting in the first line treatment regimen for many patients, These observations further reinforce the need for treatment alternatives. No randomized Phase III data exists for the patient population enrolled and treated in Piccolo.

No level one evidence, if you will. As such, there is no agreed upon established standard care for patients with later line Therefore, to design this trial, we synthesized historic data of both non platinum monotherapy and platinum containing regimens similar patient populations. These analyses drove the trial's standard sign in two stage design and its statistical assumptions. Regarding the former, we defined objective response rate as the primary endpoint. The key secondary endpoint for Quick C was duration of response. Safety and tolerability were important additional study objectives. Based upon the assumed or hypothesized objective [indiscernible] we established the trial size to rule out a confirmed objective response rate by investigators of 28%, Because an observed objective response rate exceeding 28 percent would set these data apart from the historic benchmark data I referenced above. In other words, positive trial result would require an observed or actual objective response rate that excluded 28%, based upon 95% confidence intervals.

In the fully rolled Piccolo trial at total of 79 patients have been treated. Most of whom have received prior PARP inhibitor therapy. As of today, a number of those patients remain on treatment. Continuing to receive Mirvetuximab Based upon the pre specified trial design until the response duration for the entire study population is mature, the trial remains ongoing.

However, we are able to share today that based on an interim assessment of response and safety, the primary endpoint of the study has been achieved. The investigator assessed objective response rate excludes 28%.

And we anticipate an overall objective response rate of at least 48% when we report the full data in 2024.

Also of note, to date we have detected no new safety signals with Mirvetuximab. The insights I've shared today from the ongoing piccolo trial are meaningful. As the numerically largest [indiscernible] Mirvetuximab reported thus far in patients with platinum sensitive disease we believe these data reinforce earlier previously published data sets at Mirvetuximab in combination that demonstrate Mirvetuximab's potential in FR alpha expressing platinum sensitive ovarian cancer or P SOCK. Assuming a tolerability and safety profile in PSoC that remains consistent with that, observed across the Mirvetuximab development program, We see Mirvetuximab eventually becoming a new standard of care in PSoC assuming a trajectory similar to that already underway in platinum resistant [indiscernible] In addition to evaluating Mirvetuximab monotherapy, in Piccolo, we are advancing 2 trials designed to establish Mirvetuximab combination agent of choice in platinum sensitive ovarian cancer. The first is Gloriosa. Our Phase III trial evaluating Mirvetuximab plus Teprotumumab maintenance versus standard of care, that this is a maintenance.

In the second line platinum sensitive setting.

This study builds upon our robust Mirvetuximab plus Tepacizumab data in the platinum resistant setting. Which led to the NCCN compendium listing for this combination. This combination in the maintenance setting is designed to establish the opportunity for patients to benefit from even longer duration therapy with Mirvetuximab.

The second is trial 420, single arm Phase II study evaluating Mirvetuximab plus carboplatin with Mirvetuximab continuation until disease progression in platinum sensitive ovarian cancer patients with low medium or high levels of folate receptor alpha expression, Both Gauriosa and trial four twenty are enrolling in the US and advancing in Europe. Moving to our pivotal program, we continue to anticipate top line data from the Phase II KIDENZA [indiscernible] in patients with frontline and relapsed refractory Blastic plasmacytoid dendritic cell neoplasm, or BPDCN, in 2024. Given the encouraging efficacy and tolerability data we have observed, as presented at the European Rheumatology Association annual meeting earlier this year, we are excited about feedback as a potential new option in this rare indication.

In our AML program with PIVAC, we continue to advance enrollment in our [indiscernible] trial of Tevec in combination with venetoclax and Azacitidine. Which we refer to as the PIVX triplet.

We expect to report data from this study at ASH in December. 2 cohorts enrolled patients with newly diagnosed acute myeloid leukemia and each were designed to inform the optimal schedule of the venetoclax in the PIVAC triplet. A critical first step to guide further clinical development including planned pivotal development in frontline AML. As for our earlier stage programs, on IMGC 936, our 1st in class ADAM9 targeting ADC and co development with MacroGenics, we continue to progress our non small cell lung cancer expansion cohort and we plan to provide an update after the protocol we now expect next year. Lastly, we are progressing our Phase one trial of ING N151, our next generation antibrolet receptor alpha targeting ADC, to address a broader range of folate receptor alpha expressing tumors. Initial exploration is in ovarian and endometrial cancers and dose escalation is proceeding as anticipated. With that, I will turn the call over to Lauren to cover our financials.

Lauren?

Thanks, Mike. For the Q3 of 2023, we generated $113,400,000 in revenue, including $105,200,000 in net product sales of Elohir. With the remainder primarily from non cash royalty revenues. Operating expenses were $85,300,000, comprised of $47,600,000 of R and D expenses, and $37,700,000 of SG and A expenses.

Recorded net income of $30,700,000 and EPS of $0.10.

We ended the quarter with $605,500,000 in cash on the balance sheet.

Our financial guidance for 2023 remains unchanged. We continue to expect revenues, excluding ElliHear sales, between $45,000,000 and $50,000,000, and operating expenses between $350,000,000 and three $65,000,000.

Lastly, since we are quickly approaching the end of 2023, I'd like to share that we anticipate providing full year ELL here revenue guidance for 2024 when we announced Q4 and full year 2023 financial results, With that, we'll open the call for questions. [indiscernible] And our first question coming from the line of John Newman with Canaccordion. Your line is open.

Hi there. Good morning. Thanks for taking my question, and, great continued work, successful launch. Just had 2 questions. On Ali here, curious Sure. On Ella Hair, curious if you're seeing El Aire use in combination with Avastin continue to grow, as a share of total e la hear use and also if you expecting to see increased duration of therapy here. And then 2nd, just a quick question on, what we should be looking for in terms of the tudecumab data at ASH this year? Thanks.

Yeah. I'll ask, Isabela to answer those questions. [indiscernible] Hey, John. Yes. Well, we continue we're very pleased with the performance in the Q3 as you said. Over 100,000,000 in sales. We continue to drive the station both in Monotherum in combination. While we have preliminary data on that, we could say yes, there is growth in both. And we continue to see that. And our market research indicates that that will continue to grow in the next few months. You please repeat your question on Pivotal?

Sure, John. I think John, hi. It's my Yeah. Hi, John. It's Mike. Yeah. With respect to our upcoming data at ASH, as I mentioned, in the [indiscernible] we're we're gonna have as much data as we essentially as we have on on the 2 cohort that have solidified, the dosing schedule of the triplet as we move forward in 802. So, you know, efficacy data, safety data, obviously, it's an ongoing study. And so sort of the maturation of those data with [indiscernible] is going to take more time, but I think we'll be able to expand a fair bit on what I just k. K.

Great. Thank you.

And our next question coming from the line of Michael Schmidt with Guggenheim. Your line is open.

Hey guys, good morning. Thanks for taking my questions and congrats on reaching cash flow positivity this quarter. Amazing job on the launch so far.

I'm Mark or or Isabel, could you comment a bit more what what do you think your treatment share is at this point in time in the platinum resistant ovarian cancer setting as opposed to other patient subsets in this market. It's been very strong, largely. And then secondly, could you comment on how the Piccolo trial result potentially reads through to other trials you have ongoing in a platinum center for ovarian cancer setting.

Mike, I'll start and then ask Isabel and and Mike to address the additional points here. So we aren't in a position to quote you a specific share, at at this point. The way we are looking at the business is we see some important trends. I think we've characterized this slow but steady growth as we look at the utilization of the product as monotherapy. So when we Started now. The majority of the patients were 4th and later line as time has gone by. What we see in the claims data is movement into earlier lines of therapy. And in parallel, which that, we see combination use of, of the product growing as well. And so but to sort of stand back at this point and give you a specific share number, just not in a position to do that. Miss Bell, I don't know if you want to add anything to that.

No. I just would like to say that this is an area of high unmet needs and where we are pleased is to see a steady adoption across all the accounts. And significant depth and breadth in both academic and community settings. So we expect this will continue to increase in terms of market share. We are not in a position to comment at this time.

Thanks, Mike, for the question. In terms of the pickle of data. You know, I I I I can't imagine a better foundation on which to build in platinum sensitive ovarian cancer than interim assessment that we've able to share with respect to Piccolo. This is a, just to remind you, this is a heavily pretreated population of patients with platinum sensitive disease and when we look across the available therapy, which is very heterogeneous because, there are so few options.

We see single agent monotherapy objective response rates in the high single digits to low double digits. And we see platinum based [indiscernible] objective response rates anywhere between the high twenties and and high thirties. And here we are with an interim assessment. Of an ongoing study where we expect at least a 48% objective response rate. So this sets a really nice foundation for the continued work of, of Mirvetuximab and platinum sensitive And thank you.

As a reminder, Thank you. One moment for our next question. [indiscernible] And our next question coming from the line of Esther Durek Great. Thanks for taking my questions and congrats on continued early execution here. Maybe on Piccolo, and thanks for the additional color on the study. Just wanted to know if you could comment at all on sort of the standard of care duration of response and sort of just sort of level setting expectations, from sort of a standard of care perspective for for that study. And I had a question on on ADAM 9 as well. Just thinking about sort of some of the recent data we got at ESMO from the TROOP 2 mechanism. In terms of the response dynamics potentially in sort of a squamous versus a non squamous non small cell cancer population. If you could comment at all on sort of the ATM9 mechanism and whether or not there's sort of a preference or converse preference for for for, particular sort of non squamous histology.

Sure. Azure, this is Mike. Let me respond to the second question, first. I think the long and the short of it is that at Adam 9 is broadly expressed.

And we look forward if there's any, Yeah. If there's any signal that we see that, is distinguishable based on histology when we have that expansion data will obviously be looking forward to sharing that. But at this point, given the broad across epithelial cancers. We're continuing to know, to to look broadly, in that cohort.

With respect to, the first question, I just want to reinforce that we're really looking forward mid next year sharing the full data from Piccolo And it's your questions are really going to be relevant in the context of the specific demographics, even more detailed than what we're able to share today with respect to for example, more detail around the platinum free interval on this patient population to be able to better interpret not just the interim assessment objective response rate that we're seeing, but also, the durability of response and and other factors that that are gonna be important to essentially round out this interim assessment with the full data. So we're really looking forward to that. And, like I said, I think we've shared that we expect that in mid next year.

Thank you. Thank you. And one more for our next question. And our next question coming from the line of Boris Peaker with TD Great. Congratulations on the progress. 2 questions for me.

So first on Ella here. I'm just curious what is the current duration of therapy, and how do you expect it I guess to increase in piccolo patients? And the second is maybe kind of get your general thoughts on the competitive products d s six thousand from Daiichi that's in early stage development? Yeah. Boris, the claims data that we have at this point are not sufficient to allow us to project a duration of therapy, among the patients that have been treated know, as a general rule, what we'd observe is that, longer. We reserve that same phenomenon with the with the use in in combination.

Hi, Boris. It's Mike. And with Yeah. Clearly, the the the the data you referenced that were presented, I think, last week. Are are interesting. It's a phase one experience, it looks to me, at least from the data, there's some work to do with appropriate dose it's gonna be, something that we're gonna wanna keep an eye on and think about ways in which, those data progress. But You know, we're years ahead in terms of the platinum resistant space and and and and candidly platinum sensitive space in terms of where we're at with [indiscernible] Great.

Thanks for taking my questions.

Thank you. And our next question coming from the line of Brian Cheng with JPMorgan. Your line is open.

Hey guys, congrats on the quarter and thanks for taking my question this morning. Mark, how should we think about the sales trajectory next year, you know, from a dynamics of patients on combo with Fab and the use in early line versus discontinuation just due to natural progression. How should we think about the trajectory moving forward? And then know, 2 on Piccolo, how how how should we think about the regulatory path look like post your Piccolo final analysis?

And do you think the final analysis will give you Thanks, Brian. I'll start. We expect to see continued growth. We will give guidance in conjunction with our earnings call in February of next year when we report out full year results. But for the reasons that Isabelle articulated in her opening, comments, what we see from our market research is increased testing. And that trend should continue, increasing awareness you know, right now, the survival data are not currently in the label, and so we can't directly promote that information with the, submission of the s SBLA and subsequent approval. We'll be able to go to the market, with that. And what we observed from the market research at this point is with increased education, we all increased breadth and depth of, of prescribing both as it relates to the monotherapy as well as in combination. We think there are rising treatment rates. So this is a, you know, a new therapy in an area of unmet need. We've pointed out earlier that, you know, this is the 1st drug approved specifically in ovarian cancer, in almost the last decade. And so the expectation here is that treatment rates will increase.

And then in particular with the Mirasol data, we have the ability compare and contrast against the standard of care. And when we do that, what we observed again in the research is an inclination to use the drug earlier in the treatment cascade. And so we do anticipate these questions over the course of the call and today. And so what I would say again is that we do expect continued growth I think it's also fair to say that coming off of a $100 plus 1,000,000 base, the slope of the curve will not be as steep as it was in the in the past couple of quarters.

And that's Mike, regarding Yeah. This is Mike. Regarding your, yeah, your second question, so first of all, let's just keep in mind what where we're at. Right? This is foundational data that will unequivocally be clinically meaningful in this patient population. And, the reason that the full dataset won't be available until mid 2024 is because of the importance of presenting Mature. Durability of response data. And just to keep in mind, the last patient was enrolled in this study early this year. So it gives you a sense of, of the importance of of of of of what that mature, response durability data will be.

I fully expect given what we know today, that these data will support a thing eventually when we see the full data. And I'd like to reserve judgment on dialogue with regulatory authorities until we have that that full data because no way to, context with that durability of response.

Great.

This is very helpful. Thank you.

Thank you. And our next question coming from the line of Alexandra Ramsey with William Blair. Your line is open.

Hi, everyone. Thanks so much for taking my questions and congrats on all the progress this quarter. [indiscernible] So 2 quick questions. [indiscernible] That 48 response rate that you mentioned, [indiscernible] present a confirmed 48% response rate And then looking at the Miracel data presented earlier at ESCO, it appears that the PARP3 patients actually responded better than the Part D patients. So I was just wondering if you could provide some color on why that might be the case? Thanks so much.

Yeah. So this is Mike. Regarding your second question, it's important in that subset analysis, to look at the demographics of the patient populations When the Mirasoft dataset is parsed, by prior exposure to PARP inhibitor or not. We tried to point that out in the presentation, and I encourage you to go back and look at that. But the long and short of it is There are some differences that are more apparent in the [indiscernible] And generally in terms of outcomes, it's not surprising necessarily that we see slightly better outcomes in patients that are appropriate based on their molecular profiling for PARP inhibitors. And, with respect to the first question, Yeah. So this is an interim assessment. It was a a planned interim assessment following full enrollment.

And these data are confirmed The the the one caveat I'll, say, and I think Mark mentioned this as well, is This is an ongoing trial. Right? With patients, a number of patients that are still receiving therapy, And so, you know, in the parlance of a of a of a clinical researcher, we confirm the data when we share something like this, but of course, we need to reserve you know, the the the the the caveat that when the when the full data are presented mid next year, that they're you know, that that that in the process of providing those full data, there could be [indiscernible] talk about an objective response rate of at least 48%.

Okay. No, that that makes sense. And so you are seeing kind of durability increase over time. It sounds like it based on how long People have been on on treatment, but just confirming that. Yeah. I mean, that that the issue of the maturity of the duration of response is exactly why we're providing some guidance today that we would expect the full data in mid-twenty 24.

Perfect. Thanks so much.

Thank you. And our next question coming from the line of Peter Lawson with Barclays. Your line is open.

Thanks for taking my questions. Just going back to your comments around Daich's CDH CH86. ADC. Just curious on what you thought the data and if kind of that Response rate and durability kind of holds up kind of how you think decisions will make a peak between Dacia's molecule and your molecule. And then on Piccolo, if I could just go back to that. The 48% mean there's kind of unconfirmeds there and it should get to above 48% or at 48%. So any any details around that find the detail commentary you made be great. [indiscernible] What I'll say to the 2nd point which kind of relates to the prior question is that we do see late responses you know, in our datasets generally. And, as I mentioned, there are a number of patients that remain on Mirvetuximab. So at this interim assessment, we can confidently say that, we see an objective response rate of 48 but we just need to be cognizant of, those number of patients that remain on therapy. So could the objective response rate at the final data be higher? Yes. It could be it could be higher. With respect to your first question, it's so conjectural.

I mean, like I said, we've got a Phase one molecule that Has a really interesting early signal. Like I said earlier, looks like to me, we're trying to figure out dose I think there were some grade five interstitial lung disease related deaths so Gosh. I hope for patients that, we're able to work through that and it becomes potentially someday a meaningful therapy and ovarian cancer, but I think it's a little premature from where I sit to try to hypothesize about how physicians are going to make treatment choices.

Compared to a medicine that has demonstrated survival benefit in platinum resistant ovarian cancer.

Perfect. Thanks for the additional detail. What's the overlap between [indiscernible] And CDH, it's Yes. We're looking hard to understand that. I can't give you any numbers. Today, but when we have a better understanding of that, course, we'll be able to to to share that.

Great.

Thank you so much. Congrats on the quarter.

Thank you.

Thank you. And our next question coming from the line of Kelly Shee with Jefferies. Your line is now open. Quarter, and thank you for taking my questions. I have 2 Firstly, on the regulatory approval, will you be able to share your launch strategy in Europe at the moment? And also how should we consider the cost associated with the launch?

And another question regarding the item 9 program. So for the upcoming update in non fossil one ten could you share what interim analysis is based on Is it a response rate or the durability of response?

Thank you.

I'll just briefly respond to the 2nd question, and I think Mark or Isabelle may tackle your question about Europe. So this is a cohort expansion of a phase one study. And so it's, It's essentially think about it as sort of fully enrolling that cohort and having this data to be able to share that in totality. It's nothing really more complicated than that. And patients remain in the cohort.

It's just, prudent to, on therapies. It's prudent to, to wait for for that to mature, and we look forward to sharing, those data next year.

Great, thanks. And so in terms of Europe, I'll start and then ask Isabel to comment further. But we were very pleased to announce last week that the EMA had validated our marketing authorization application. And we think that sets us up very nicely for an approval late next year. In terms of the launch sequence, we're on the ground already in Europe with established headquarters in Switzerland and a small staff to support the key functions around market access regulatory and the like and are starting to build team, to support initial sales in, in Germany. And then there'll be [indiscernible] Subsequent countries added on as, as as we go forward. And then I'll let Isabelle talk a little bit about the market and, overall, the the comment here is that we can address this market with, a modest incremental investment for the business, but maybe just talk a little bit about the dynamics there.

Yes, Mark. Thank you. Well, as we have shared previously, the market in Europe is highly concentrated and really the majority of the centers 65 centers account for about 80 percent of the patients there. So as Mark alluded to with a small investment, we are able to reach this [indiscernible] We also had started already our engagement. And as you saw, we presented at ESCO and ESMO, and we have very strong relationships with KOS in Europe that are really excited to have this setup be available to them [indiscernible] very much, supporting our efforts in this. In addition to that, we are gearing up, our team in suit in Germany, in other countries, and we are very excited to start our market research, our preparations to basically replicate the success of the launch that we had seen in the U. S.

And one other point to add to that, which is, Kelly, our physician base there has tremendous experience with the drug already. So when we look at Mirasol, when we look at Soraya, more than 70% of the patients were enrolled outside of the United States and the vast majority of those were enrolled in Europe. And so this is a group of physicians that has already significant experience with the drug. So we're excited about our prospects there.

Terrific. Thanks. [indiscernible] Thank you. And our next question coming from the line of Astika Kewardin from Truist. Your line is open. Hi, guys. Good morning. Thanks for taking my questions.

First off, congrats on another robust quarter for us guys, especially coming in line with the aggressive buy side expectation. That's good to see. Totally understand that you can't be too specific on off label use here, but can you at least give us some sort of a bit of color here on what off label population is the largest in what you're seeing so far and what is growing the most rapidly. I I think that could just be a little helpful here for us as we're tweaking our models here.

And then on Piccolo, good to hear about what the ORR is trending at.

But what about duration of response? You've given us what the statistical bars are, can you tell us what you need to beat for DOR? And then I'll also add in previous calls, I think you and I'm since you guys had mentioned that suggested that that this could be also an area where, where where people look could look good. So just wanna see if you feel confident about that as well, not if you're seeing more of the data in house. And then, lastly, do you need to publicly present Tikolo in order to discuss it with the NCCN, or can you share that with So let me start with the market question, and then you can talk about Piccolo and and the and and CCN. So in terms of discretionary use of this label, the first thing to keep in mind is that our label is platinum resistant ovarian cancer. And patients who've received 1 to 3 prior, lines of therapy who are FR alpha positive.

So, what we observed very early on was that consistent with the NCCN guidelines that physicians were using the product in later line patients. So beyond a patient who had 3 prior therapies. And that that continues as as we speak. We then observed that, there are patients who might not be that might not qualify as FR alpha high, who nonetheless are getting therapy as monotherapy, where the FR alpha expression is close to what would be considered FR alpha high. Just as a reminder to folks, FR alpha high is defined as patient's tumor sample expressing FRL at 2 plus intensity staining. And so when 2 readouts One is positive and negative based on whether it meets that cut point of 75 or 2 plus intensity standing. But also there's a numerical score with respect to the expression levels. It's stated in 5 percentage points increments. So 75, 80, 80, 5 up to a100, and then downwards for 70, 60 5 and so on. What we hear anecdotally to market in our advisory board is that many physicians with a 70% reading will initiate, [indiscernible] As the f r alpha expression levels go down, there's the opportunity to engage around combination use.

And again, the NCCN guidelines are supportive here, where they include use of the product for patients with medium and low levels of expression. And so we as I said, we see use in later lines. It's a little hard to we can't sort of match a patient who had a 70% level of expression with, monotherapy used at this point. The the data aren't we're not able to from a data perspective to match those 2 things. And then we do see, you know, an increasing use of, of combination and it comes through most prominently, in, our market research. Relative to the claims data, which lags a little bit. And, you know, I think a number of of you on the call have have produced your own sort of market research studies. And so, you know, on both existing and anticipated increasing use of combination therapy. I don't know if you want to add anything to that.

Yes. I just wanna say awareness of NCCN guidelines has increased. And it has been included in some of the pathways to some of the centers. And NCCN guidelines are silent around high, millions are low and monitored in addition to listing the value of the combination. So in addition to being using laser lines of therapy, yes, we see, use on medium particular in combination.

And, this is Mike. With respect to your 2nd, 3rd and 4th questions. Let me make a point about this patient population that perhaps I haven't been quite explicit enough about. [indiscernible] But when a patient with natural history who has still platinum sensitive disease in 3rd or subsequent line, there's an important dichotomization around the relative platinum sensitivity that a clinician is thinking about when they think about appropriate therapy at this stage.

And, and and that's important as we think about the full data when we see those data next year, because The durability of response just like the objective response rate are going to be influenced whether the patient population has a platinum free interval that's relatively short versus a platinum free interval that's relatively [indiscernible] And you can imagine or hypothesize that it's clinician is even considering a monotherapy non platinum agent in a clinical trial. Like Mirvetuximab that when we see the final data, I would expect that we have a substantial proportion of patients that have a short relatively short platinum free interval. And that's really important to help interpret the full dataset, along with the proportion of patients that have prior exposure to PARP inhibitors and Bevacizumab. So it's all of those clinical factors and demographics that need to be incorporated into the interpretation of the data to be able to, put the data into context with respect to the objective response rate and and durability of And with respect to your question around NCCN, think a working assumption should be that, the NCCN is looking for published data sets to review in the context of updating their guidelines.

Awesome. Thanks for taking all my questions, guys.

Appreciate it.

We have time for 1 more question.

Certainly. Our last question are coming from the line of Lee Chen with H. Wainwright. Your line is open.

Hi. This is Lee Chen for Artech. Can you hear me okay?

Yep.

So just upon the conversion from accelerated approval of Ella here to full approval, I believe that Taquita under the license agreement with Taquita, there's additional Payment.

Can you provide more details on that?

So I can comment on the HwaDeng license, and that does call for additional milestone payments upon full approval. We'll comment on the exact amount of those. I would have to get back to you on the on the Takeda license.

Okay. [indiscernible] [indiscernible] Okay. Well, thank you all. For joining us today. Obviously, we are very pleased with the progress in the business. We've got an important and growing product We look forward to continued progress there. So we look to expand geographically and also moving this drug into earlier lines of therapy. Got an important 2nd pivotal program ongoing as we speak, an exciting portfolio. And you'll hear more from us as we go forward about reinvesting in the pipeline in our research capabilities. We think that ADCs are an important and growing class of therapeutics. We've got a highly differentiated skill set as it as it relates to that class of therapy. So again, look forward to keeping you updated and we'll see many of you at Ash. Thanks.

Ladies and gentlemen, that does conclude our conference for today. Thank you for your participation. You may now disconnect. [indiscernible]