ImmunoGen, Inc.

Good morning and welcome to Immugen's Third Quarter 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 Okonik, Senior Director of Corporate Communications and Investor Relations. Please go ahead.

Good morning and thank you for joining today's call. Today, we issued a press release that includes a summary of our recent progress and third 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 ImmuneEngine.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 recent accomplishments for the business, our financial results, and anticipated upcoming events. During the discussion, we will use forward-looking statements with respect to our business strategy, the development and benefits of our product candidates, the presentation of clinical data for our product candidates, the anticipated timing of regulatory submissions to the FDA and EMA for certain product candidates, our 2021 financial outlook, and our projected cash runway. This information is subject to risks and uncertainties. Our actual results may differ materially from such statements and include those described in the risk factors section of our most recent annual report on Form 10-K and our other SEC filings. With that, I'll turn the call over to Mark.

Thanks, Courtney. Good morning, everyone, and thank you for joining us today. In the third quarter, we advanced our pipeline and continued our pre-launch activities as we look to transform Immunogen into a fully integrated oncology company in the coming year. Starting with our lead program, Mervituximab, Soriftanthine, and platinum-resistant ovarian cancer, I am pleased to say that we are on track to report top-line data from our Pivotal Soraya study this quarter. For this release, we expect to include data on the primary endpoint of overall response rate, as assessed by Investigator, the sensitivity analysis of overall response rate as assessed by blinded independent central review, the key secondary endpoint of duration of response, and the safety and tolerability profile of Mervituximab. We believe these data will provide a comprehensive picture of the results of the trial. We are planning for success with Soraya, and to that end, our preparations for the BLA are well underway, with the goal of submitting the application before the end of Q1, along with activities in support of the potential launch of Mervituximab in the second half of next year. In addition to Sirea, we are pursuing a broad program to establish Mervituximab as the new standard of care for patients with folate receptor alpha positive ovarian cancer. Our confirmatory Mirasol trial continues to enroll, and we expect top-line data in the third quarter of next year. If positive, these data could enable full approval of Mervituximab in the U.S., and importantly, support an application for marketing authorization in the EU. This past quarter, we also initiated Piccolo, a single-arm study of Mervituximab monotherapy designed to address the increasing unmet need for an effective non-platinum option for FR-alpha-high recurrent platinum-sensitive ovarian cancer. Beyond Mervituximab monotherapy, we have generated encouraging data with Mervituximab in combination with Bevacizumab and Carboplatin. We believe Mervituximab has the potential to become the combination agent of choice for ovarian cancer, and we look forward to sharing our label-enabling combination strategy next quarter. As we continue to expand our team, we are very pleased to welcome Dr. Helen Thackrey to our board of directors. Her deep development and regulatory expertise will be invaluable, both in the near term, as we look to bring Mervituximab to market, and longer term for our full portfolio. With that, I'll turn the call over to Anna to provide an update on the rest of our development pipeline. Anna?