ImmunoGen, Inc.

Good morning and welcome to Immunogen's third 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 Annabelle Chen, head of investor relations. 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 operating progress in third quarter 2022 financial results. This press release, a recording of this call, and an updated corporate deck can be found under the investors and media section of our website at immunogen.com. With me today are Mark Ennedy, our president and CEO, Anna Birkenblatt, our chief medical officer, and Susan Altshuler, CFO. During today's call, we will review recent accomplishments for the business, our Q3 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 quarterly report on Form 10-Q, and in our other SEC filings, which are available at sec.gov and immunogen.com. With that, I'll turn the call over to Mark.

Good morning, and thank you for joining us today. With approval expected on or before our November 28th PDUFA date, we've taken the last quarter to complete our preparations to launch Mervituximab this month. Just to put a finer point on these activities, our highly experienced field team is fully staffed and out engaging with customers, Our distribution, market access, and patient support infrastructure is in place, and we have vials of commercial-ready drug product and inventory awaiting labeling and packaging. With this strong foundation in place, we are ready to rapidly deliver Merv to patients upon approval. As part of our preparations, we have recently updated our ovarian cancer market model, which draws on data from a couple of external sources. First, this market is highly concentrated with roughly 4,300 physicians treating just over 80% of ovarian cancer patients in the United States. At launch, we will be taking a targeted approach to drive adoption by focusing as an initial priority on a subset of 400 physicians that treat roughly one-third of patients. Looking to the market opportunity, our estimate of the eligible patient population is based on data from DRG, which indicate that there are 19,500 drug-treatable second through fourth line platinum-resistant ovarian cancer patients in the US each year. Roughly 35 to 40% of these patients express high levels of FR-alpha, and 75% currently receive single-agent chemotherapy or non-vebacizumab regimens. This gives us a market opportunity of roughly 5,200 patients for our anticipated initial label. We will also seek NCCN compendium listing for the MERV BEV combination immediately after approval, which would add another 1,800 FR-alpha high patients, giving us a total market opportunity of 7,000 patients in the platinum-resistant setting. As we will discuss later in the call, we have also initiated studies to move into recurrent platinum-sensitive disease which would bring the total U.S. market opportunity for MIRV and recurrent ovarian cancer to above 11,000 patients. We've included an updated market slide as part of our corporate deck posted on our website today. On the topic of ongoing development, we expect to report top line data from the confirmatory MIRASOL trial early next year and look forward to sharing those data as we pursue full approval in the U.S. and initial regulatory filings in the EU. We are also advancing our efforts to move Merv into platinum-sensitive populations and have activated the first sites in both the Gloriosa and Trial420 studies to address these patients. Moving to our PVEC program, in August, we shared an important update on our pivotal Cadenza study in frontline BPDCN, and we'll provide more detail on this study, but in short, Following initial analysis showing significant activity in patients with de novo disease and those who presented with a prior or concomitant hematologic malignancy, we aligned with FDA that the efficacy of valuable population will be in de novo patients. As a result, we now expect to report top line data in 2024. Also of note, we will be presenting initial data from our PVEC triplet expansion cohort in AML at ASH in December. This will be the fourth consecutive oral presentation for PVEC at ASH. Anna will cover both the MERV and PVEC programs in just a moment. Looking at the rest of the pipeline, we anticipate sharing initial data before year end from the phase 1 dose escalation of IMGC936, our first-in-class ADAM9 targeting ADC and co-development with macrogenics. We've also made meaningful progress on our phase 1 study of IMGN151 and expect to put the first patient on study before the end of the year. With that, I'll turn the call over to Anna to provide additional color on our development programs. Anna?