ImmunoGen, Inc.

Good morning, and welcome to Immunogen's first quarter 2022 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 Okonik, 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 in first quarter 2022 financial results. This press release and a recording of this call can be found under the Investors in Media section of our website at ImmuneEngine.com. With me today are Mark Ennedy, our President and CEO, Anna Birkenblatt, our Chief Medical Officer, Kristen Harrington-Smith, our Chief Commercial Officer, and Susan Altshuler, our CFO. During today's call, we will review recent accomplishments for the business, our Q1 financial results, and highlight upcoming anticipated events. We will be making forward-looking statements based on our current expectations and beliefs, These statements are subject to risks and uncertainties, and our actual results may differ materially. Please consult the risks outlined in our press release issued this morning, in the risk factors section of our most recent annual report on Form 10-K, and in our other FCC filings, which are available at fcc.gov and immunogen.com. And with that, I'll turn the call over to Mark.

Good morning, and thank you for joining us today. Building on the strong SREA data and capital raised late last year, we've continued to make excellent progress in 2022. Our top priority is to gain approval for MIRV monotherapy in patients with folate receptor alpha-high platinum-resistant ovarian cancer, and we recently achieved two critical milestones to that end, the presentation of results from our positive pivotal SREA trial at SGO and the submission of the BLA to FDA for potential accelerated approval. As we progress towards our goal of becoming a global, fully integrated oncology company, Since the start of the year, we've also continued enrollment in the confirmatory Phase III Mirasol and Phase II Piccolo studies with MIRV monotherapy, expanded our commercial team and accelerated launch preparations in anticipation of a MIRV approval, further accrued patients in our pivotal Cadenza study of PVEC and BPDCN, initiated expansion cohorts in both relapsed and frontline AML patients combining PVEC with azacitidine and venetoclax, and progressed our earlier stage programs, IMGC 936 and IMGN 151. To expand on these points, starting with MIRV, enrollment in our confirmatory Mirasol trial accelerated following the release of top-line results from Sirea. This is an event-driven study, so enrollment is not the only factor in the timing of the top-line analysis. Based upon a re-forecast generated in conjunction with the recent pre-specified interim futility analysis for Mirasol, we now expect to reach the requisite number of PFS events in the fourth quarter of this year and report top-line data from Mirasol in early 2023. Anna will provide more color on this and our label expansion studies in a moment. Our second pivotal program, PVEC, is progressing nicely and we expect preliminary efficacy data from our pivotal cadenza study in frontline BPD-CN before year-end. In addition, patient enrollment is ongoing in our Phase 1B-2 expansion cohorts, evaluating PVEC, azacitidine, and venetoclax in both relapsed and frontline AML patients, which are accruing rapidly. We expect to share data from both cohorts at ASH later this year. Looking at the rest of our pipeline, we anticipate sharing initial data before year-end from the Phase I dose escalation trial of IMGC936, our first-in-class ADAM9 targeting ADC, which we are co-developing with Macrogenics. In addition, a manuscript describing the preclinical evaluation of IMGC936 was recently accepted for publication in Molecular Cancer Therapeutics and will soon be available online. We also made meaningful progress addressing the CMC information request from FDA regarding our Phase I study of IMGN151, and expect to initiate the clinical study by mid-year. With our progress to date and meaningful catalysts ahead, we believe we are well-positioned to create significant value as we move through the remainder of the year. With that, I'll turn the call over to Anna to provide additional color on the Mervituximab program. Anna?