ImmunoGen, Inc.

Good morning and welcome to the Unigine's first quarter of 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'Connor, Senior Director of Corporate Communications and Investor Relations. Ma'am, 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 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 Ennedy, our President and CEO, Anna Birkenblit, our Chief Medical Officer, and Susan Altshuler, our CFO. During today's call, we will review key accomplishments for the business over the last three months, our financial results, and anticipated upcoming events. During the discussion, we will use forward-looking statements, and our actual results may differ materially from such statements. Descriptions of the risks and uncertainties associated with an investment in immunogen are included in our SEC filings. And with that, I'll turn the call over to Mark.

Thanks, Courtney. Good morning, everyone, and thank you for joining us today. I'll begin with our lead program, Mervituximab. We recently completed enrollment in SREA, which is our pivotal single-arm study in platinum-resistant disease, which has shifted the anticipated timing of top-line data from the third into the fourth quarter of this year and the projected submission of the BLA into the first quarter of 2022. We've also experienced some COVID-related impact on accrual for our confirmatory Murasol trial and correspondingly now expect the readout on the primary endpoint to move from the second to the third quarter of 2022. Anna will provide some more color around the updated timelines in a moment. Importantly, with positive results from these studies, we continue to anticipate potential accelerated approval of Mervituximab in 2022 and full approval in 2023. Beyond platinum-resistant ovarian cancer, we've submitted a protocol for a single-arm study of Mervituximab monotherapy in recurrent platinum-sensitive disease and anticipate initiating patient enrollment for this cohort in the second half of this year. This study further expands our approach to displacing single-agent chemotherapy in later lines of treatment in ovarian cancer. Turning to Mervituximab in combinations, we were pleased to learn that mature data from our phase 1b forward 2 doublet of Mervituximab plus Avastin in patients with platinum agnostic disease were accepted for an oral presentation at ASCO this year. In addition, a 70-patient IST led by Dr. Rebecca Aaron at UAB is now underway evaluating Mervituximab in combination with carboplatin in the neoadjuvant setting. Finally, we're supporting a randomized study comparing Mervituximab combined with carboplatin to standard of care in patients with recurrent platinum-sensitive disease in a large IST led by Philip Harder in the AGO in Germany, with patient enrollment expected to start in the second half of this year. We continue to advance our second pivotal program, IMGN 632 and CD123 positive hematologic malignancies. Having established a path to full approval in BPDCN, we are progressing our phase one expansion cohort in frontline patients and expect to generate top line data in the first half of 2022 with potential approval next year. We are also advancing 632 in combination studies with azacitidine and venetoclax and relapsed and refractory and frontline AML patients and look forward to presenting data from these combinations at ASH in December. Moving to our earlier stage pipeline, we presented preclinical data at AACR for our first in class ADAM9 targeting ADC IMGC936, which we are co-developing with Macrogenics. We also continued IND enabling activities for our next generation folate receptor alpha targeting ADC IMGN151 and expect to submit an application by year end. 2021 and 2022 are critical years in Immunogen's evolution as we prepare to bring two products to the market and further our innovative portfolio of transformative ADCs for solid tumors and hematologic malignancies. We look forward to keeping you apprised of our progress as we generate clinical data and prepare for commercialization. And with that, I'll turn the call over to Anna to provide some additional color on our clinical programs. Anna?