On November 8, 2024 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, reported its financial results for the fiscal quarter ended September 30, 2024 and provided an update on recent developments (Press release, IGM Biosciences, NOV 8, 2024, View Source [SID1234648025]).

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"The third quarter was transformative for IGM, punctuated by the announcement of our strategic pivot to focus exclusively on autoimmunity," said Mary Beth Harler, M.D., Chief Executive Officer of IGM Biosciences. "Our near-term focus for imvotamab remains generating robust initial data sets in rheumatoid arthritis, systemic lupus erythematosus and myositis. Based on enrollment timing, we expect to have sufficient information by the middle of 2025 to present initial imvotamab data at an appropriate venue as well as determine next steps to advance imvotamab in autoimmune indications."

Pipeline Updates

Imvotamab (CD20 x CD3 T cell engager)

•Clinical development of imvotamab in autoimmune diseases advances, with initial clinical data disclosure expected by mid-2025.
•
hird dose cohort in rheumatoid arthritis successfully completed. The Company has cleared the third dose cohort of its placebo-controlled clinical study testing imvotamab in severe rheumatoid arthritis.
•Enrollment in second dose cohort in systemic lupus erythematosus ongoing. The Company has cleared the first dose cohort of its open-label clinical study testing imvotamab in severe systemic lupus erythematosus (SLE) and is currently enrolling patients in a second dose cohort.
•First patient dosed in myositis. The Company has dosed the first patient in its single arm, open-label clinical study testing imvotamab in moderate-severe idiopathic inflammatory myopathies (myositis). Enrollment is ongoing in this study, which is being conducted in collaboration with Stanford University.
•Imvotamab preclinical data selected for poster presentation at ACR Convergence 2024. The Company will present a poster titled "Imvotamab, a CD20-Targeted Bispecific IgM T Cell Engager, Effectively Depletes Low-Expressing CD20+ B Cells in Preclinical Models of Autoimmune Disease" at the American College of Rheumatology’s annual meeting, ACR Convergence 2024, taking place in Washington, D.C., on November 17, 2024.
IGM-2644 (CD38 x CD3 T cell engager)

•Clinical development of IGM-2644 in autoimmune diseases to be initiated. The Company continues to make significant progress towards initiating clinical development of IGM-2644, a CD38 x CD3 T cell engager antibody, in the
treatment of autoimmune diseases. The Company expects to enter IGM-2644 into a single arm, open-label clinical study for generalized myasthenia gravis (gMG) by the end of 2024.
Corporate Updates

•Peer-reviewed article titled "Cutting-edge Approaches to B-cell Depletion in Autoimmune Diseases" published in Frontiers in Immunology. IGM co-authored this article with Bill Robinson, M.D., Ph.D., et al. and the article can be found online here. Dr. Robinson is Chief of the Division of Immunology and Rheumatology at Stanford University.
•Eric Humke, M.D., Ph.D., Senior Vice President, appointed as Head of Clinical Research and Development. Dr. Humke joined IGM in 2019 as Vice President, Clinical Development. Prior to IGM, he spent eight years at Genentech, most recently serving as Senior Medical Director, where he led the early clinical development of multiple first-in-human therapeutics. Prior to joining Genentech, he was an Instructor of Medicine at the Stanford University School of Medicine, where he conducted basic science research and cared for patients.
Third Quarter 2024 Financial Results

•Cash and Investments: Cash and investments as of September 30, 2024 were $218.8 million, compared to $337.7 million as of December 31, 2023.
•Collaboration Revenue: For the third quarter of 2024, collaboration revenues were $0.5 million, compared to $0.5 million for the third quarter of 2023.
•Research and Development (R&D) Expenses: For the third quarter of 2024, R&D expenses were $46.1 million, compared to $54.8 million for the third quarter of 2023. R&D expenses for the third quarter of 2024 included $5.5 million in one-time expenses related to the strategic pivot to focus exclusively on autoimmunity.
•General and Administrative (G&A) Expenses: For the third quarter of 2024, G&A expenses were $18.8 million, compared to $12.5 million for the third quarter of 2023. G&A expenses for the third quarter of 2024 included $8.5 million in one-time expenses related to the strategic pivot to focus exclusively on autoimmunity.
•Net Loss: For the third quarter of 2024, net loss was $61.4 million, or a loss of $1.01 per share, compared to a net loss of $62.0 million, or a loss of $1.04 per share, for the third quarter of 2023.

2024 Financial Guidance

The Company expects full year 2024 GAAP operating expenses of $215 million to $225 million including estimated non-cash stock-based compensation expense of approximately $40 million, and full year collaboration revenue of approximately $2 million related to the Sanofi agreement. The Company expects to end 2024 with a balance of approximately $180 million in cash and investments and for the balance to enable it to fund its operating expenses and capital expenditure requirements into 2027.