Good morning, ladies and gentlemen, and welcome to ImmunoGen's fourth quarter and full year 2021 financial and operating results conference call. Today's conference is being recorded. At this time, I'd like to turn the call over to Courtney O'Konek, Senior Director of Corporate Communications. Please go ahead. Good morning, and thank you for joining today's call. Earlier today, we issued a press release that includes a summary of our recent progress and fourth quarter and full year 2021 financial results. This press release and a recording of this call can be found under the Investors and Media section of our website at immunogen.com. With me today are Mark Enyedy, our President and CEO, Anna Berkenblit, our Chief Medical Officer, and Susan Altschuller, our CFO. Kristen Harrington-Smith, our Chief Commercial Officer, will also join us for Q&A. During today's call, we'll review recent accomplishments for the business, our financial results, and highlight upcoming anticipated events. We will use forward-looking statements with respect to our business strategy, the development and benefit of our product candidates, the design of our clinical trials, the presentation of clinical trial data for our product candidates, the anticipated timing of clinical trials and regulatory submissions to the FDA for certain product candidates, the anticipated commercial launch for certain product candidates, financial guidance, and our cash runway. Each forward-looking statement is subject to risks and uncertainties that could cause our actual results to differ materially from such statements. These risks and uncertainties include those described in our press release issued this morning and in the Risk Factors section of our most recent annual report on Form 10-K and our other SEC filings, which are available at sec.gov and on our website at immunogen.com. The forward-looking statements in this presentation speak only as of the original date of this call, and we undertake no obligation to update or revise any of these statements. With that, I'll turn the call over to Mark. Good morning, everyone, and thank you for joining us today. 2021 was a productive year for ImmunoGen with significant progress across the business as we move towards our objective of becoming a fully integrated oncology company. In particular, we delivered resoundingly positive results in SORAYA, our pivotal study for mirvetuximab in ovarian cancer, generating compelling data with IMGN632 in AML, advanced our earlier stage programs, established a plan to reignite our research engine, laid the groundwork to support our first commercial launch, and executed the single largest financing in the history of the company. With this progress, we've generated significant momentum in the business as we enter 2022. To expand on these points, starting with our lead program, mirvetuximab soravtansine in ovarian cancer, our top priority this year is to gain accelerated approval for mirvetuximab as a monotherapy in patients with folate receptor alpha positive platinum-resistant disease. To this end, we believe the positive top-line SORAYA data reported in late November position us for initial approval in this setting with significant unmet need. We're on track to submit the BLA for mirvetuximab by the end of this quarter and are preparing for potential accelerated approval and launch in the second half of the year. We also expect to generate data from our confirmatory MIRASOL trial in the third quarter, which is intended to support full approval. As part of our comprehensive strategy to move mirvetuximab into broader patient populations and become the combination agent of choice in ovarian cancer, we've designed a number of additional company-sponsored studies and in parallel are supporting investigator-sponsored trials for mirvetuximab, which Anna will discuss in further detail shortly in the call. In step with advancing the mirvetuximab program towards regulatory approval, we began building our commercial and medical affairs organizations, now led by our Chief Commercial Officer, Kristen Harrington-Smith, and our Head of Medical Affairs, Dr. Mimi Huizinga. Launch preparations for mirvetuximab are well underway and are focused on four key priorities, redefining expectations for positive outcomes with mirvetuximab in platinum-resistant ovarian cancer, supporting adoption of early folate receptor alpha testing and establishing standards for in-house and centralized testing, ensuring positive physician and patient experiences through tailored education and guidance for patient management, and seeking broad payer access and reimbursement in delivering a seamless patient experience. We're off to a strong start building best-in-class sales, marketing, and medical education teams and have most recently added our Head of Sales. Our second program, pivekimab sunirine, formerly known as IMGN632, is progressing nicely. We've advanced our pivotal CADENZA study in BPDCN and expect top-line data in the front-line cohort in the second half of this year. In addition to BPDCN, we were pleased to present data from the triplet regimen evaluating pivekimab sunirine in combination with azacitidine and venetoclax in relapsed refractory AML during an oral session at ASH and are encouraged by the safety profile and efficacy observed, particularly in the higher intensity cohorts. Based on these data, we've initiated an expansion cohort for the triplet in relapsed patients and expect to move into front-line patients during the year. Regarding our earlier stage portfolio, dose escalation continues in the phase I trial of IMGC936, our first-in-class ADAM9 targeting ADC, which we are co-developing with MacroGenics in multiple solid tumor types and anticipate sharing data from this program later this year. We also submitted the IND for IMGN151, our next generation anti-folate receptor alpha ADC. Due to a delay in drug product production at our vendor, FDA placed a hold on our IND application pending responses to some CMC-related information requests. We are generating the data responsive to these requests and look forward to enrolling our first patient following submission of this information to the agency. Turning to business development, we were pleased to announce a multi-target global licensing deal with Eli Lilly earlier this month. This deal demonstrates the strength of our technology and leadership in ADCs and generates value from our intellectual property around our proprietary camptothecin platform. Lastly, we completed an upsized follow-on offering that generated roughly $295 million in gross proceeds in the fourth quarter, and we ended the year with over $475 million in cash. These funds, together with product and collaboration revenues, will support the business through the initial launch of mirvetuximab and other material inflection points and into 2024. With that, I'll turn the call over to Anna to provide some additional color on our clinical programs. Anna? Thanks, Mark. We are extremely pleased by the positive top-line results from our pivotal SORAYA trial. Recall that despite advances in the front line in platinum sensitive settings, most patients with ovarian cancer eventually relapse with platinum-resistant disease. Treatment options for platinum-resistant ovarian cancer are limited, consisting primarily of single-agent chemotherapy, which has limited activity, with objective response rates ranging from 4%-13% and considerable toxicities. Having aligned with FDA on the substantial unmet need in this population, SORAYA was designed as a single-arm study of mirvetuximab in patients with platinum-resistant ovarian cancer whose tumors express high levels of folate receptor alpha and who have been treated with 1-3 prior lines of therapy, including prior bevacizumab. The primary endpoint of confirmed objective response rate, or ORR, as assessed by investigator, was 32.4%, well over double the expected response with single-agent chemotherapy. Five of the responses were complete responses, which doesn't happen very often with available therapy in platinum-resistant disease. Median duration of response, or DOR, is a key secondary endpoint and was 5.9 months as of the data cutoff on November 16, 2021. With nearly half of the responders still receiving mirvetuximab at that time, the duration of response continues to evolve. These results are particularly encouraging in light of the heavily pretreated population in which 51% of patients had three prior lines of therapy. All patients received prior bevacizumab, and 48% had received a prior PARP inhibitor. Turning to safety, the profile in SORAYA is consistent with the known safety of mirvetuximab, which has now been studied in over 800 patients. The most common adverse events were low-grade, reversible, ocular, and GI events managed with supportive care and dose modifications if needed. The tolerability of mirvetuximab is demonstrated by the low 7% discontinuation rate for treatment-related adverse events, including just one patient in SORAYA discontinuing for an ocular adverse event. No corneal ulcers or perforation have been reported. As in prior studies, the ocular events were predictable, manageable, and reversible. Looking ahead, Dr. Ursula Matulonis will present the full SORAYA data set at SGO during the plenary late-breaking abstract session on Saturday, March nineteenth. Data will include updated duration of response and key subgroup analyses, including patients with three prior lines of therapy and those who received a prior PARP inhibitor. Progression-free survival data will also be presented. As mentioned, we are on track to submit the BLA for mirvetuximab before the end of the first quarter in support of potential accelerated approval later this year. In support of full approval, the confirmatory MIRASOL study of mirvetuximab is expected to read out in the third quarter of 2022. We also continue to enroll patients in PICCOLO, a single-arm study of mirvetuximab monotherapy in approximately 75 patients with folate receptor alpha high recurrent platinum sensitive ovarian cancer intended to support label expansion. PICCOLO is designed to address the increasing unmet need for an effective non-platinum option in later lines of platinum-sensitive disease. With an overall response rate of 64%, our phase I data show a potential for mirvetuximab in this patient population. We have formalized our strategy to position mirvetuximab as the combination agent of choice. With compelling data from the mirvetuximab plus bevacizumab doublet in patients with folate receptor alpha high recurrent ovarian cancer, we expect to gain compendia listing for this combination in close proximity to the initial monotherapy approval of mirvetuximab. These data also support our design of GLORIOSA, a potential label-enabling phase III study in the second-line platinum-sensitive maintenance setting. About a third of second-line platinum-sensitive patients receive a platinum doublet plus bevacizumab followed by bevacizumab maintenance. The addition of bevacizumab to a platinum doublet provides an overall modest improvement in PFS of approximately 3-4 months in this setting, highlighting the limitations of available therapy. GLORIOSA is designed to evaluate the PFS benefit of mirvetuximab plus bevacizumab maintenance versus bevacizumab maintenance alone in all patients who have not progressed following completion of their platinum doublet plus bevacizumab. Approximately 440 patients will be randomized to either mirvetuximab plus bevacizumab or bevacizumab alone for maintenance. The primary endpoint is progression-free survival. Secondary endpoints include overall survival and overall response rate. We anticipate initiating GLORIOSA in the second quarter of this year. Given the promising activity we've seen with the mirvetuximab plus carboplatin doublet in phase I dose escalation in recurrent platinum sensitive disease across a range of folate receptor alpha expression with an ORR of 80% and median duration of response of 24 months in FR alpha medium and high patients, we recently announced the planned initiation of Trial 0420. Trial 0420 is a single-arm phase II study of mirvetuximab plus carboplatin, followed by mirvetuximab continuation in approximately 110 patients with folate receptor alpha low, medium, or high platinum sensitive ovarian cancer. The data from this study will inform our path to registration in this setting. Moving to pivekimab sunirine, our CD123-targeting ADC. We presented initial safety and efficacy findings from the phase I/II study of pivekimab sunirine in combination with azacitidine and venetoclax in patients with relapsed refractory AML in an oral session at ASH in December. Demonstrating an ORR of 48% in all relapsed refractory AML patients, these data are encouraging, particularly in higher intensity cohorts where we observed higher response rates, including an ORR of 59% and a 38% composite complete remission rate. Importantly, the pivekimab sunirine triplet demonstrated no tumor lysis syndrome, veno-occlusive disease, capillary leak or cytokine release. These data reinforce the potential of pivekimab sunirine as a new combination therapy for AML, which unfortunately is characterized by poor outcomes despite available therapies. We have opened an expansion cohort in relapsed AML patients and plan to initiate a frontline expansion cohort later this year. At ASH, we presented pivekimab sunirine monotherapy data featuring vignettes from 3 frontline BPDCN patients in a poster session. All 3 patients achieved clinical complete remission, and pivekimab sunirine was associated with limited grade 3 or greater treatment-related adverse events and no capillary leak syndrome. We continue to enroll patients in the U.S. and Europe in CADENZA, our pivotal phase II study in frontline and relapsed refractory BPDCN, anticipate top-line data during the second half of 2022, and believe pivekimab sunirine has the potential to become a best-in-class monotherapy treatment option for BPDCN patients. With that, I'll turn the call over to Susan to cover the financials. Susan? Thanks, Anna. Starting with our results for the full year 2021. We generated $69.9 million in revenue, $46.8 million of which came from non-cash royalty revenues. The remainder came from license and milestone fees, which include recognition of $14.6 million of the $40 million upfront fee previously received under the company's collaboration agreement with Huadong Medicine and $7.4 million of revenue from partner milestones. Operating expenses were $194.9 million, comprised of $151.1 million of R&D expenses compared with $114.6 million in 2020, and $43.8 million of G&A expenses compared with $38.6 million in 2020. We ended 2021 with $478.8 million in cash on the balance sheet. Turning to our financial guidance for 2022. We expect revenues to be between $75 million-$85 million, operating expenses between $285 million-$295 million, and cash and cash equivalents at year-end between $245 million-$255 million. Given the range and timing for potential approval of mirvetuximab, revenue guidance does not yet include potential product sales from mirvetuximab. We expect that our current cash, combined with the anticipated product and collaboration revenues, will fund operations comfortably into 2024. With that, I will turn the call over to Mark for closing comments. Thanks, Susan. We entered this year with a motivated and strong team and exciting prospects for the business. Between now and the end of the year, we expect to launch our first product, report pivotal data for pivekimab sunirine, advance our early-stage programs and further build our pipeline and research capabilities. We have the right strategy, leadership and resources in place to generate significant value in the near and long term, and I look forward to more good days for our people, our business, and our patients. With that, we'll open the call for questions. Ladies and gentlemen, if you'd like to ask a question at this time, you will need to press the star then the one key on your touchtone telephone. To withdraw your question, you may press the pound key. Please stand by while we compile the Q&A roster. Now, first question coming from the line of John Newman of Canaccord. Your line is now open. Hi, guys. Good morning. Thanks for taking my question. Congrats on the continued progress. Two quick questions. First one is for the progression-free survival data from SORAYA at SGO, just curious if we'll see both investigator assessed and independently assessed? On pivekimab sunirine or IMGN632, just curious as to what patient population and potential combinations you're considering for a future pivotal study? Thanks. Anna? Hi, John. Yeah, at SGO, we will have the full data set from SORAYA, which will include overall response rate, duration of response subsets, and we will include PFS data as well. I would encourage folks to come to SGO to assess the PFS data, and we will have an investor event shortly thereafter. Moving on to the pivekimab question. In terms of future pivotal trials, we are thinking about the triplet, pivekimab plus azacitidine plus venetoclax in relapsed refractory AML, based on the data that we have already generated in phase I dose escalation, and now we're exploring in an expansion cohort that potentially could support a single-arm study in the relapsed setting. In addition, we plan to explore a frontline setting for this triplet, and should those data look promising, then we could consider a frontline randomized phase III trial to support approval for that triplet in the frontline setting. Okay, great. Thank you. Now next question coming from the line of Michael Schmidt from Guggenheim Securities. Your line is open. Hi, good morning. This is Yige for Michael. Congrats on the progress and thanks for taking our questions. Two quick questions from us. Number one, for MIRASOL, Anna, could you please help us understand the mix of the patients with and without prior bevacizumab? How are the two groups different in baseline characteristics, and how might that impact their response to Mirv? The second question, can you talk about your camptothecin ADC platform that you licensed to Lilly? How is the payload different from other type one topoisomerase-targeted ADC? Thank you. Anna? For MIRASOL, the patient population will include both patients with and without prior bevacizumab, similar to FORWARD I, the prior phase III study where we had a mixture of patients. In FORWARD I, about half of the patients had prior bevacizumab and half did not. We anticipate a similar patient mix in MIRASOL. When you think about which patients get bevacizumab, they tend to be patients with worse prognosis and are more heavily pretreated. Let me start with the worst prognosis and then move to heavily pretreated. Bevacizumab is approved in several settings for ovarian cancer. The only one of which that has demonstrated an overall survival advantage is in the first-line setting for poor risk patients. These are patients with stage IV disease, suboptimally debulked, ascites, et cetera. Many physicians often reserve bevacizumab for those worst patients, particularly in Europe. We can see that actually in the SORAYA study when you come to SGO in terms of the demographics of the patients enrolled in terms of their stage of disease. Moving to number of prior lines of therapy also, bevacizumab, it's hard for us in prior studies to tease apart bevacizumab versus number of prior therapies. You know, as a point of reference to support that, in the FORWARD I study, 65% of patients had 1-2 prior lines of therapy and 35% had 3 priors. You may recall that in SORAYA, 51% of patients had 3 prior lines of therapy. The SORAYA population is more heavily pretreated and potentially a worse population than what we anticipate seeing in the MIRASOL study based on the prior FORWARD I study. Moving to the next question on camptothecins. Our camptothecin payloads are specifically designed to address potent antitumor activity and have basically unique properties from a chemical perspective that give broad IP coverage for us. I think that's what I can say at this point. I don't know, Mark, if you wanna add any color to the camptothecin payloads. Yeah, maybe just a little broader observation here. You know, we take some pride in having multiple classes of payloads to apply to ADC. You know, we've got at least three generations of maytansines. We have our indolinobenzodiazepine DNA acting payloads, and we're looking for additional classes. Our team, you know, engineered this, you know, this new version of the camptothecins with the goal of broadening the therapeutic index versus what we see with some of the other camptothecins that have been deployed in the ADC context. We've got very good preclinical data supporting that we've been able to, you know, drive activity at least in that range with better tolerability. We're excited about that. Lilly was excited about that and are moving forward with the tech transfer for them for their targets while at the same time advancing internal programs that will deploy that payload. Thank you very much. Sure. Now next question coming from the line of Etzer Darout with BMO Capital Markets. Your line is open. Great. Thanks for taking the question. The first one for me, you know, with respect to PFS in SORAYA, I guess how meaningful is this update from your perspective in this late line post bev, you know, setting? And will we see benchmarks for this specific population at SGO? And then secondly, on IMGN151, given sort of the CMC submission update, are you still on pace to start the phase I in the first half of this year? Thank you. Yes. Yep, I'll take the PFS question, and then. Yes. -we can, uh- Perfect. I'll turn it over to you, Mark, for the IMGN151 question. Regarding SORAYA, you're absolutely right. The population is a late line post Bev setting. Frankly, this is one of the most heavily pretreated populations that has been studied in platinum-resistant ovarian cancer in a study this size. There are no good benchmarks. What I can tell you is there are multiple studies that have been published showing in ovarian cancer, as in other solid tumors, the law of diminishing returns, if you will. With each line of therapy, the expectations for ORR, duration of response and progression-free survival diminishes. When you get to these really later line patients, physicians' expectations regarding efficacy are quite low given their experience. Certainly, you know, the data that we've shared with the investigators on the SORAYA study, they're quite pleased with the totality of the efficacy data that we have shared with them in terms of ORR, duration of response and PFS. Because, as I said, the expectations that they have for these patients later line post Bev setting is quite low. What I will tell you is that we will share data at SGO to put the PFS data from SORAYA into context based on what we've known from prior studies of mirvetuximab. As you've seen, we've replicated the overall response rate data in SORAYA that we had previously gathered in that 70 patients of foundational data that basically created the hypothesis that we have tested in SORAYA and now confirmed. Again, we'll have the data and put it into context for you at SGO. Mark, over to you for 151. Yeah, thanks. Just to reiterate the point that we made in the introductory comments, this is a CMC and not a clinical issue. You know, in order to issue a study may proceed letter for an IND, the FDA requires the sponsor to submit CMC data relating to the drug, including drug product stability. Most often, those data are included in the IND submission. In some cases, the sponsor will make the data available to the agency during the review period. In the case of IMGN151, we plan to submit the required data during the review period. However, due to delays at our drug substance vendor, we were not able to secure a drug product production slot as we had planned, which meant that we weren't in a position to update the IND during the review period. The agency put us on hold. We've now secured our drug product slots for this quarter, and we will generate the required data and expect to come off clinical hold in due course. It's too early to give updated guidance in terms of we will be delayed, but it's too early to give updated guidance on the timeline for first patient in, but we will update you when we've got a better sense following the DP run. Got it. Thank you, and congrats on all the progress. Thank you. Now our next question coming from the lineup. Boris Peaker with Cowen, your line is open. Great, thanks. Maybe, looking forward to the SGO, I think a lot of investors are going to be focused obviously on the PFS results and use that as a basis to estimate the probability of success of MIRASOL. Maybe you could help us try to understand how we should be thinking of translating the PFS from SORAYA to MIRASOL quantitatively. Thanks, Boris. You know, I think we have actually much better data to guide PFS from FORWARD I to MIRASOL. What I mean by that is that PFS in a single arm study like SORAYA is really not interpretable. You don't have a control arm to tease apart the antitumor activity from the underlying tempo of disease. That's why FDA does not use PFS when they are looking at antitumor activity to support accelerated approval. It's about ORR and DOR. If people want to assess the probability of technical success for MIRASOL, I would encourage them to review the data that we've already generated in FORWARD I. Recall that FORWARD I was the randomized phase III study of mirvetuximab versus investigator choice chemotherapy. In the FR alpha high subset identified by the PS2 scoring method, that is the population that we're basically replicating in MIRASOL. In FORWARD I, we demonstrated a median PFS in that population of 5.6 months. The hazard ratio in FORWARD I, based on either investigator or blinded independent review, was around 0.6. You may recall that in MIRASOL, we designed the study to target a hazard ratio of 0.7, much more conservatively. We've already run the experiment in FORWARD I. The population in MIRASOL will be essentially the same in terms of platinum resistance, 1-3 priors, FR alpha high, about half of them having prior bevacizumab. The one difference is that we'll have a higher percentage of patients with PARP inhibitors now, and we've already demonstrated in SORAYA, and you'll see the full data at SGO, that mirvetuximab has very nice activity regardless of prior PARP use or not. From our perspective, the SORAYA data increased the probability of technical success for MIRASOL because we now have that answer about prior PARP inhibitors. Thanks, Boris. Got it. My second question is on the CADENZA study in BPDCN. Could you set expectation what you need to show in the study for approval? The statistical design for CADENZA is really allowing us to enroll a cohort of up to 20 patients in this ultra-rare indication. There's somewhere between 500 and 1,000 new patients a year in the U.S. and similarly in Europe. Looking at the efficacy data for the one approved agent in BPDCN, we know that the CR/CRi rate is in the 40%-50% range. We would need to demonstrate a CR/CRi rate in that range with nice efficacy. From a statistical perspective, that based on the sample size that we're using, that rules out this 10% CR/CRi rate that FDA guided us to. Got it. Thank you for taking my question. Sure. Our next question coming from the line of Andy Hsieh with William Blair. Your line is open. Great. Thanks for taking my questions, and congratulations on all the progress last year. So first question has to do with all the new trials. So, Anna, I'm just curious if you have, you know, kind of decided on the trial design for GLORIOSA in terms of treatment duration in the maintenance phase. Maybe a step back, can you use this trial as a confirmatory study for PICCOLO? I know that sometimes, you know, FDA allows you to confirm using kind of a different patient population. And the second question is for Kristen. I'm just curious, as you prepare to launch mirv, have you decided on how the drug will be distributed? So specifically, I'm curious about the ordering and delivery system. Is that mostly on demand? If that's the case, how should we think about the gross to net? Thank you. Sure. We're really excited about the GLORIOSA study, which is a study of adding mirvetuximab to maintenance bevacizumab versus maintenance bevacizumab in the recurrent platinum sensitive setting. Why are we excited about this? Because we've already generated beautiful data in the treatment setting for the mirv/bev doublet, showing response rates of 59% in platinum resistant disease, 69% in platinum sensitive disease that are, you know, above the benchmarks. We wanna move that active, well-tolerated doublet into the maintenance setting. We know that patients, once they have recurrent platinum sensitive disease, more and more of them will have already had a PARP inhibitor in the front line setting. Using a triplet in the recurrent platinum sensitive setting makes a whole lot of sense. With that, we will take all patients who have completed their triplet in terms of the carboplatin doublet portion of it, and as long as they haven't progressed, so they have a CR, a PR, or stable disease, they will be randomized to mirv/bev versus bev alone. You may recall that in this setting, that entire treatment path for bevacizumab only, bev only adds about 3-4 months of progression-free survival. Adding mirvetuximab, you know, a non-cross resistant targeted cytotoxic, we anticipate that we will have responses on the mirv/bev arm, and there will be a long treatment duration on the mirv/bev arm, really benefiting patients. The primary endpoint is progression-free survival. The study also has sufficient power for us to demonstrate an overall survival advantage, and that could really transform the treatment paradigm for these patients. Regarding your question about confirming whether or not GLORIOSA could stand in as a confirmatory trial for PICCOLO, it's a little too soon for us to work that through. You know, PICCOLO is enrolling now, and we need to engage with FDA on the exact criteria for a path toward accelerated approval. I would stay tuned for that. Let me turn it over to Kristen now. Thanks, Anna. To respond to your question, we do plan on using a 3PL, so like you said, an on-demand or drop ship model. This is to help us with our gross to net. At this time, that's all we would like to comment on gross to net. Does that help? Yeah. Okay. So I guess the question is really, you know, how would the kind of gross to net differ from other, you know, other drugs or more traditional distribution? That's kind of where I am curious about. Our goal is to avoid many of the wholesaler fees. Okay. That's better. Andy, is that fair? I mean. Perfect, Mark. Yeah, no, no. I mean, when you look at the patient numbers and volumes here, there's no need to have, you know, a massive amount of inventory sitting at wholesalers, you know, awaiting to be distributed. It's much more efficient from our perspective. Most of the ADCs use this model of, you know, setting up a 3PL, and then having the, you know, the orders come in and fulfilling those using the drop ship model. In doing that and setting up a very streamlined approach here, we're avoiding a lot of the fees that are attendant to having inventory sitting at a wholesaler. We can't tell you right now. Right. Got it. Got it. We can't tell you right now what exactly the gross to net would be, and that probably wouldn't be a good idea in the first instance. Right. Okay. That's really helpful. Thank you so much. Anna, I'm curious. Is there like a fixed duration for the maintenance phase for GLORIOSA? Is it like one year, you know, 18 months or 2 years? I'm just curious if that's been set. Yeah. In the frontline setting, when you do maintenance trials, there is a fixed duration because there's a chance that some of your patients are gonna be cured. Once you have recurrent platinum-sensitive disease, the expectation is that you're not cured. Patients will be treated until progression and intolerable toxicity or, you know, intolerable toxicity. I have to say, I mean, across the MIRV program, we've had patients on mirvetuximab for 1 year, 2 years, 3 years, even up to 4 years, and still going. You know, in terms of the tolerability of mirvetuximab as a monotherapy, we know that it's quite well tolerated. With the MIRV bev, we've had patients on that doublet for a good long time as well, both in the platinum-resistant and the platinum-sensitive setting. You know, I can't tell you an estimated duration and maintenance in the recurrent platinum-sensitive setting, but it's gonna be long because you know, we know that the PFS of these patients is gonna be quite long. Great. Thank you so much for answering all my questions. Thanks, Andy. Our next question coming from the line of Kelly Shi with Jefferies. Your line is open. Good morning. This is Han calling in for Kelly Shi. First, thanks. First, congratulations on the great quarter. My question is really for the MIRASOL trial, given the assumption for the median PFS, the chemo arm is about 3.5 months. Do you see any risk that the control arm might outperform given that more options of chemotherapy are available for the control arm? My second is regarding the ECOG 0-1 performance status. Do you see that may also influence the patient outcome in the control and treatment arm and how the patient in terms of the consistent weight of the 0-1 status is consistent from the FORWARD I trial to SORAYA and the, you know, MIRASOL trials? Okay. Your question about the progression-free survival estimate on the control arm of MIRASOL. We have designed it for 3.5 months because that's pretty much what every study in platinum-resistant ovarian cancer has shown. I would remind you that in FORWARD I, for the FR alpha high subset, we actually had a median PFS of 3.2 months. You know, there are some studies out there suggesting that FR alpha is a poor prognostic factor, so it may be with single agent chemotherapies, patients with high FR alpha do worse than the overall population. If anything, I think the control arm on MIRASOL might underperform, not outperform. I didn't understand your comment about it might outperform because more options are available. The options on the MIRASOL control arm are topotecan, paclitaxel, and Doxil, just like they were in the FORWARD I study. These are all drugs that have been approved and, you know, 20 years ago. It's not like now there's much better therapies. Unfortunately, we're using the same old single agent chemotherapies that have been around for a couple of decades. If anything, I think the control arm in MIRASOL might underperform, but we certainly didn't design it assuming that it needed to, you know, for success of the study. Moving to ECOG performance status 0 or 1. You know, the ECOG performance status is 0 means people feel perfectly well. ECOG status of 1 means they're a little tired. The lower the performance status, the worse patients do. That's why we've excluded patients with poor performance status, 2, 3, or 4, because that's when you know that the risks of whatever you're studying begin to potentially outweigh the benefits because the patients just aren't fit enough. Given the population that we've enrolled across the mirvetuximab program, ECOG status is 0 or 1. We typically have a similar distribution across all the studies, and we do not anticipate any difference from an efficacy or a tolerability perspective for either subset of patients. Great. Thank you so much. That's very helpful. Our next question coming from the line of Kennen MacKay with RBC Capital. Your line is open. Hey, good morning, and thanks for taking the question. Just one on the SORAYA filing plans. Is the data from SORAYA sufficient for the Ventana full FRα companion diagnostic and accelerated approval of the diagnostic as well? Or is there additional data from MIRASOL or other trials in the future that's also needed or again just in a confirmatory sense? And then on the MIROVA trial, can you maybe talk about the rationale for that trial and that carboplatin plus mirvetuximab doublet and potentially what the next steps there could be? Thanks. Sure. I'll take the CDx question, and then, Anna, you can talk about the IST with Harter. The answer is yes. The data from SORAYA are sufficient to support the approval of the companion diagnostic. I think as we've discussed previously on these calls, we're working with Ventana, which is Roche Tissue Diagnostics. They've actually submitted the PMA in four modules. They've already submitted the first module. They have our clinical data, which is being integrated into the subsequent modules, and they will file in close proximity to our BLA submission, which would put them on track to have the CDX approved at the same time as the drug. For the MIROVA study, this is a randomized phase II investigator-sponsored trial in Germany led by Dr. Philipp Harter. It's approximately 140 patients who will be randomized 1:1 to mirvetuximab plus carboplatin, followed by mirvetuximab continuation versus carboplatin doublet of choice, followed by maintenance of choice. The idea here is, you know, when you talk to physicians about mirvetuximab, they want to be able to replace paclitaxel with our drug because patients don't lose their hair, we have less neuropathy. This is the first opportunity for us to really combine mirv plus carbo in a larger study, for Dr. Harter to do so and compare it directly to standard carboplatin doublets, which include carbo-paclitaxel, carbo-Doxil and carbo-gemcitabine. This study will help us get a better sense of the tolerability profile of the doublet because at this point our database is, you know, limited, but also the antitumor activity, efficacy, in the recurrent platinum-sensitive setting head-to-head against available therapies. This data set from MIROVA will help guide further development of mirvetuximab plus carboplatin as a doublet. I should point out it is one of three prongs that we are taking to understand the potential of mirvetuximab plus carboplatin. The second prong is a neoadjuvant study, IST here in the U.S., led out of Ohio State. That study is in the neoadjuvant setting, the first time we can get mirvetuximab in untreated patients up front with tumor tissue available at the time of their debulking surgery. The third is Trial 0420 that you heard about earlier, which is mirvetuximab plus carboplatin in a broader population of FRα-positive tumors. Among those three data sets, we will then have sufficient data to support the registration path for the mirvetuximab plus carboplatin doublet. Got it. Thanks, Anna. Maybe just one follow-up. You'd mentioned that there's certainly some evidence and some publications out there to support the fact that patients with folate receptor positive disease or folate receptor high positive disease potentially have worse outcomes. Is there any other data that the team is working on or that might become available that could be used to sort of further support that fact or be added to the SORAYA accelerated approval submission? Or if not, what data set do you see as the most supportive for that? Thank you. We do not need any data regarding FRα as a prognostic factor to support our SORAYA study and our path toward accelerated approval. We know that FRα is predictive of benefit from mirvetuximab. We have a biomarker-identified population in SORAYA, FRα high patients who clearly benefit from mirvetuximab with a near tripling of the response rate, clinically meaningful duration of response, and very nice tolerability. FRα is clearly predictive of benefit from mirvetuximab. The one data set that we can point to now that is more robust in terms of answering this prognostic question really is the FORWARD I data set, where we did the post hoc analysis looking at mirv versus chemotherapy. 'Cause again, you need this control arm, right? Because that's where you're assessing how patients do with available therapies, where we inadvertently enrolled the low, medium, and high patients. You can see with the higher the FRα expression, the worse patients do with investigator choice chemotherapy, be it response rate, or progression-free survival. I think frankly, that's the only data set that we're gonna have for a while, Kennen, because now that we know, we're focused on the FRα high patients, approximately, you know, 40% of all of the ovarian cancer patients who benefit the most from mirvetuximab. I mean, down the road, maybe with mirvetuximab plus carboplatin, when we demonstrate very nice activity across a broader spectrum of FR alpha patients, and we do a randomized trial there, maybe then we'll have a mix of patients where we can circle back on this question of it being a prognostic factor. But really from a development perspective, and for physicians to understand who benefits the best from mirvetuximab, it's FR alpha high patients, and that's what matters the most. Got it. Thanks again, and looking forward to seeing you at SGO. Thanks. Our next question coming from the line of Jessica Fye with J.P. Morgan. Your line is open. Hey, guys. Good morning. Thanks for taking my question. Maybe one more specific one on SGO. Should we expect to see a swim plot, a spider plot, a waterfall at SGO? And also, will we see a PFS Kaplan-Meier curve or just the median PFS number? Come to SGO, Jess. We will have visualizations of the data for you to understand the data. Okay, great. On the platinum sensitive setting, can you talk about what you see as the bars, either for approval or for further development for the phase III evaluating mirvetuximab plus bev maintenance in the folate receptor high platinum sensitive setting as well as for that, mir-carbo combo, with mirvetuximab continuation in the kind of broader folate receptor alpha expressing population? Sure. In terms of the bar, we have designed GLORIOSA, the randomized phase III study, to support full approval. The primary endpoint is progression-free survival. It's about 440 patients, and the hazard ratio we're aiming for is around 0.7, or that's what it's designed for. This study is designed in a robust manner to demonstrate superior efficacy for mirvetuximab plus bevacizumab versus bevacizumab alone. In terms of the bar for mirvetuximab plus carboplatin, that doublet, we would anticipate needing a randomized phase III study for that doublet. Again, we would need an adequately powered randomized phase III study with a control arm of standard available platinum-based doublets. That should answer your question, Jess, 'cause these are both randomized trials. I think where the bar is less clear, to be honest, and the unmet need is increasing, is in the later-line platinum-sensitive patients that we are studying in the PICCOLO study. That's a population where I think the unmet need is increasing, and the bar there is not clear. We've already generated a handful of data supporting going forward with the PICCOLO study, and we look forward to engaging FDA on what the bar would be in that setting to support approval from a single-arm trial for an accelerated approval. Got it. Thank you. Our next question coming from the line of Arthur He with H.C. Wainwright. Your line is open. Hey, good morning, everyone. Thanks for taking my question. Most of my question have been answered. I just wonder, could you guys give us more color on the advantage for the camptothecin platform? If possible, could you guys give us more color on the partnership with Eli Lilly? Sure. I mean, we covered most of what we have said publicly about this program. You know, our chemists were looking for an additional payload. We noted that Daiichi was enjoying success with their camptothecins. The question was, as a medicinal chemistry exercise, could we design, you know, a better topoisomerase I inhibitor that's of the camptothecin class, that, you know, would expand the therapeutic index for the payload, either by better tolerability, better efficacy or both. What we think we have is a molecule with at least equivalent efficacy with better tolerability and we think potentially better bystander killing with this molecule. You know, that's been the That's the basis, and then I can't really comment on the financials of the deal beyond what's included in the press release that we issued last week or the week before. Thank you for the additional color and congrats on the progress this quarter. Thank you. Our next question coming from the line of Joseph Catanzaro with Piper Sandler. Your line is open. Hey, guys. Thanks so much for taking my question here. Maybe one, just quick one from me. If I think back to FORWARD I think it took about 10 months or so from enrollment completion to readout. Just wondering why there will be a shorter window for MIRASOL. I know it's not maybe apples to apples, but maybe you could help us better understand that dynamic, whether it be enrollment kinetics, event rate or other things, and if there's risk that the readout could be pushed beyond 3Q. Thanks. You're spot on. Enrollment kinetics influence the timing of the readout. Progression-free survival is the primary endpoint. It's an event-driven study, right? We will trigger the analysis for the primary endpoint when we reach the requisite number of events. And that is a function of both the enrollment as well as the timing of the events. The event rate in MIRASOL is and should be similar to the event rate in FORWARD I, given that we're enrolling very similar populations. The enrollment rate in MIRASOL has been different from FORWARD I. With FORWARD I, we had a very brisk enrollment the last three months. Like, it just shot up like crazy. A whole bunch of patients were enrolled right at the very end. We had to wait a good long time to get to the requisite number of progression-free survival events. Here, with MIRASOL being a larger study, and with the pandemic, you know, we don't anticipate that super-duper sharp tail in enrollment, like the curve right up. We're on track for top line data in Q3. Okay, got it. That's really helpful. Thanks for taking my question. Sure. Now our next question coming from the line of Jonathan Chang with SVB Leerink. Your line is open. Hi, guys. Thanks for taking my questions. A couple non-MIRV questions for me. First question, can you provide any color on your revenue guidance of $75 million-$85 million? You noted that this doesn't include potential product sales from mirvetuximab. If you could provide any color as to what's reflected in this guidance, that'd be helpful. Then the second question is, can you provide any additional color on how the IMGC936 dose escalation is going and any additional granularity on when initial data could be disclosed this year? Thank you. Great. Susan? Yep. On the revenue guidance, we include our non-cash royalty revenues, and the license and milestone fees inclusive of the $75 million-$85 million. We don't include the MIRV product revenues because we don't have an approval date yet, of course. The timing of potential revenues would be a factor in that. That's what's inclusive in the revenue guidance. Turning to IMGC936, we are in dose escalation for this novel ADC with a novel, ADAM9-directed, antibody and the first, DM21 linker payload. We are in dose escalation, and we look forward to presenting data later this year once we've identified the recommended phase II dose and schedule, and then we'll be able to also share plans for further development in, ADAM9-positive tumors. Got it. Thank you. That's all the time we have for our Q&A session. I would now like to turn the call back over to Mr. Mark Enyedy for any closing remarks. Great. Thanks everybody for joining us today. We're excited about the year ahead. We have a number of important events upcoming, starting with SGO in a couple of weeks, and we look forward to talking to all of you then. Thanks very much, and we'll keep you updated on our progress. Ladies and gentlemen, that does end our conference for today. Thank you for your participation. You may now disconnect.