7/29/2022

speaker
Operator
Conference Operator

good morning and welcome to immunogen second 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 chan 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

speaker
Annabelle Chan
Head of Investor Relations

and second quarter 2022 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 Ennedy, our President and CEO, Anna Birkenblith, 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 Q2 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 pre-release issues this morning, in the risk factor section of our most recent annual report on Form 10-K and quarterly report on Form 10-Q, and then our other SEC filings, which are available at sec.gov and immunogen.com. And with that, I'll turn the call over to Mark.

speaker
Mark Ennedy
President and CEO

Good morning, and thank you for joining us today. This past quarter, we've made significant progress across the business, and importantly, FDA accepted the BLA for MERV with a priority review designation and set a producer date of November 28th. Our ongoing interactions with FDA have been productive, and in conjunction with our mid-cycle review, we were advised that the agency has no plans for an advisory committee at this time. As we transition into a global, fully integrated oncology company, we are actively preparing for the potential launch of MERV monotherapy for patients with folate receptor alpha positive ovarian cancer. Kristen will provide an update on our launch readiness progress later in the call. In terms of ongoing development, We're pleased to report that our confirmatory Phase III Mirasol trial is now fully enrolled, and we expect to share top-line results from this study in early 2023. We are also advancing our efforts to move MIRV into broader patient populations. To that end, we are expanding our development program and are in the process of initiating the Gloriosa and Trial 420 studies. Moving to our second pivotal program, PVEC, we are pursuing cohorts in BPDCN and AML and anticipate reporting important data in both of these indications later this year. Anna will cover both the MERV and PVEC programs in more detail. Lastly, with the progress in our pivotal programs, we are reinvesting in our research capabilities and deepening our earlier stage pipeline as exemplified by our recent research collaboration with Oxford Biotherapeutics to develop novel ADCs. We look forward to deploying our proprietary linker payload technology against the targets identified by OVT to address cancers of high unmet need. So with an exciting first half of the year and a number of important milestones ahead, we believe we are well positioned to create meaningful value for our patients and our shareholders in both the short and long term. With that, I'll turn the call over to Anna to provide additional color on our clinical programs. Anna?

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