ImmunoGen, Inc.

Good morning, ladies and gentlemen, and welcome to Immunogen's fourth quarter and full year 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 Okanek, 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 and fourth quarter and full year 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 Birkenblatt, our Chief Medical Officer, and Susan Eltshuler, our CFO. Kristen Harrington-Smith, our Chief Commercial Officer, will also join us for Q&A. During today's call, we'll review recent accomplishments for the business, our financial results, and highlight upcoming anticipated events. We will use forward-looking statements with respect to our business strategy, the development and benefit of our product candidates, the design of our clinical trials, the presentation of clinical trial data for our product candidates, the anticipated timing of clinical trials and regulatory submissions to the FDA for certain product candidates, the anticipated commercial launch for certain product candidates, financial guidance, and our cash runway. Each forward-looking statement is subject to risks and uncertainties that could cause our actual results to differ materially from such statements. These risks and uncertainties include those described in our press release issue this morning and in the risk factor section of our most recent annual report on Form 10-K and our other SEC filings, which are available at sec.gov and on our website at immuneengine.com. This forward-looking statement and this presentation speak only as of the original date of this call, and we undertake no obligation to update or revise any of these statements. With that, I'll turn the call over to Mark.

Good morning, everyone, and thank you for joining us today. 2021 was a productive year for Immunogen, with significant progress across the business as we moved towards our objective of becoming a fully integrated oncology company. In particular, we delivered resoundingly positive results in Sirea, our pivotal study for Mervituximab and ovarian cancer, generated compelling data with IMGN 632 and AML, advanced our earlier stage programs, established a plan to reignite our research engine, laid the groundwork to support our first commercial launch, and executed the single largest financing in the history of the company. With this progress, we've generated significant momentum in the business as we enter 2022. To expand on these points, starting with our lead program, Mervituximab, soroftanzine, and ovarian cancer, our top priority this year is to gain accelerated approval for Mervituximab as a monotherapy in patients with folate receptor alpha-positive platinum-resistant disease. To this end, we believe the positive top-line TREA data reported in late November position us for initial approval in this setting with significant unmet need. We're on track to submit the BLA for Mervituximab by the end of this quarter, and are preparing for potential accelerated approval and launch in the second half of the year. We also expect to generate data from our confirmatory Murasol trial in the third quarter, which is intended to support full approval. As part of our comprehensive strategy to move Mervituximab into broader patient populations and become the combination agent of choice in ovarian cancer, we've designed a number of additional company-sponsored studies and, in parallel, are supporting investigator-sponsored trials for Mervituximab which Anna will discuss in further detail shortly in the call. In step with advancing the Mervituximab program towards regulatory approval, we began building our commercial and medical affairs organizations, now led by our Chief Commercial Officer, Kristin Harrington-Smith, and our Head of Medical Affairs, Dr. Mimi Huizenga. Launch preparations for Mervituximab are well underway and are focused on four key priorities. redefining expectations for positive outcomes with Mervituximab and platinum-resistant ovarian cancer, supporting adoption of early folate receptor alpha testing and establishing standards for in-house and centralized testing, ensuring positive physician and patient experiences through tailored education and guidance for patient management, and seeking broad payer access and reimbursement in delivering a seamless patient experience. We're off to a strong start building best-in-class sales, marketing, and medical education teams, and have most recently added our head of sales. Our second program, Paveka Madison Nearing, formerly known as IMGN 632, is progressing nicely. We've advanced our pivotal cadenza study in BPDCN and expect top-line data in the front-line cohort in the second half of this year. In addition to BPDCN, we were pleased to present data from the triplet regimen evaluating PVEC in combination with azacitidine and venetoclax and relapsed refractory AML during an oral session at ASH and are encouraged by the safety profile and efficacy observed, particularly in the higher intensity cohorts. Based on these data, we've initiated an expansion cohort for the triplet and relapse patients and expect to move into frontline patients during the year. Regarding our earlier stage portfolio, dose escalation continues in the phase one trial of IMGC936, our first in class ADAM9 targeting ADC, which we are co-developing with macrogenics and multiple solid tumor types and anticipate sharing data from this program later this year. We also submitted the IND for IMGN151, our next generation antifoliate receptor alpha ADC. Due to a delay in drug product production at our vendor, FDA placed a hold on our IMD application pending responses to some CMC-related information requests. We are generating the data responsive to these requests and look forward to enrolling our first patient following submission of this information to the agency. Turning to business development, we were pleased to announce a multi-target global licensing deal with Eli Lilly earlier this month. This deal demonstrates the strength of our technology and leadership in ADCs and generates value from our intellectual property around our proprietary Camp to Thesis platform. Lastly, we completed an upsized follow-on offering that generated roughly $295 million in gross proceeds in the fourth quarter, and we ended the year with over $475 million in cash. These funds, together with product and collaboration revenues, will support the business through the initial launch of Mervituximab and other material inflection points and into 2024. With that, I'll turn the call over to Anna to provide some additional color on our clinical programs. Anna?