IGM Biosciences, Inc.

Good day, everyone, and welcome to IGM Biosciences' fourth quarter and full year 2022 financial results and corporate update call. Today's call is being recorded. At this time, I would like to turn the call over to Fred Schwerzer, Chief Executive Officer of IGM.

Thank you, Operator, and thanks to all of you joining us on this call. On behalf of IGM, I'm joined today by Mishpat Tahir, Chief Financial Officer. Dr. Chris Takamoto, Chief Medical Officer, Dr. Bruce Kite, Chief Scientific Officer, and Dr. Mary Beth Harler, President, IGM Autoimmunity and Inflammation. Please note that we will be making forward-looking statements on this call, including statements about IGM's plans, expectations and forecasts, and about future events. Actual results may differ materially as a result of various risks and uncertainties, including those discussed in the company's most recent annual report on Form 10-K, as well as its other filings with the SEC. Any forward-looking statements represent IGM's view as of today, March 30, 2023 only, and the company disclaims any obligation to update these statements, except as required by law. Following this call, a replay will be available on the company's website, www.igmbio.com. I would like to start with a few introductory remarks, and then I will turn the call over to MISPA to take you through our 2022 financial results. After MISPA's update, Chris will update you on clinical development of IgM 8444, our death receptor 5 agonist antibody. Next, Mary Beth will update you on our development plans for imvodumab and autoimmune diseases. We will then turn it back over to Chris to discuss the true most recent product candidates in our oncology pipeline. IgM 7354, our IgM-targeted immunostimulatory IL-15 cytokine, and IgM 2644, our CD38 by CD3 T-cell engager, a next generation CD38 antibody for multiple myeloma. Looking back, 2022 was a transformational year for IgM. At the end of the first quarter, we entered into an important collaboration with Sanofi to develop novel IgM agonist antibodies to address three oncology targets and three autoimmune targets. Throughout the year, we also continued the clinical development of our death receptor 5 agonist antibody, IgM8444, particularly in combination with Fulfuri for the treatment of colorectal cancer. We're very pleased with the data we have seen from those clinical development efforts as we announced in January of this year. These data have provided the basis for our decision to immediately move into a randomized study of IgM8444 in second-line metastatic colorectal cancer in combination with Fulfuri and Bevacizumab, which is the standard of care in second-line colorectal cancer. We are hopeful that this randomized study will show a significant improvement in progression-free survival relative to the standard of care chemotherapy control arm. As we announced today, we have now treated the first patient in this randomized study. We also made great progress during 2022 in developing our understanding of the potential role of our T-cell engagers, such as Invotimab, in treating autoimmune diseases. We are encouraged by the expanded safety and efficacy data for Invotimab at 100 milligrams that we have developed through our clinical studies in non-Hodgkin's lymphoma, and we believe that Invotimab's safety profile may be an important differentiating factor in the exciting new field of T-cell engagers in autoimmune disease. Building on our success in 2022, we expect that 2023 will also be an important year for the expansion and validation of IgM's platform. Already this year, we have treated the first patients in our clinical study of IgM 7354, an IgM-targeted immunostimulatory IL-15 cytokine, which could be used for the treatment of patients with fallen and hematologic malignancies. We are particularly excited about the potential to use IgM-7354 in combination with cellular therapies such as CAR-T and CAR-NK cells. We are also initiating studies of IgM-2644, our CD38 by CD3 bispecific IgM antibody. which we hope will be a safe and more potent form of anti-CD38 therapy for multiple myeloma, including for patients who have previously been treated with daratumumab. We also plan to file investigational new drug applications and initiate clinical studies for invodumab in multiple autoimmune diseases this year, beginning with lupus and rheumatoid arthritis. At this point, I'd like to turn the call over to Misbah to review our financial results for 2022.

Thank you, Fred. In addition to the brief financial overview I will provide on the call today, you can read additional detail on our fourth quarter and year-end financial results in our press release issued prior to this call and in our 10-K, which was filed with the SEC. We are fortunate to be in a strong financial position. In the second quarter of 2022, we received an upfront payment of $150 million from Sanofi related to our collaboration agreement and raised gross proceeds of $230 million in a follow-on public equity offering. As a result, our cash and investments total $427.2 million as of December 31, 2022. In the fourth quarter, our research and development expenses were $45 million. For the full year 2022, R&D expenses were $179.3 million. General and administrative expenses for the fourth quarter of 2022 were $11.6 million and $49.7 million for the full year 2022. Collaboration revenues for the fourth quarter of 2022 were $0.4 million and $1.1 million for the full year 2022. Our net loss for the fourth quarter of 2022 was $52.6 million or a loss of $1.19 per share. For the full year 2022, our net loss was $221.1 million, or a loss of $5.32 per share. Turning now to the financial guidance for 2023, we expect our full year 2023 GAAP operating expenses to be between $290 million and $300 million. This includes estimated non-cash stock-based compensation expense of approximately $50 million. For the full year 2023, we also expect to recognize approximately $3 million of collaboration revenue related to last year's upfront payment from Sanofi. Finally, we expect to end 2023 with a balance of approximately $200 million in cash and investments providing IgM with an expected cash runway into the second half of 2024. With that, I'll now turn the call over to Chris, our Chief Medical Officer.