IGM Biosciences, Inc., a clinical-stage biotechnology company based in Mountain View, California, has reported its financial results for the fiscal quarter ending June 30, 2024. Alongside these financials, the company provided significant updates on the progress of its clinical trials and product candidates.
Fred Schwarzer, the CEO of IGM Biosciences, highlighted the advancement of their two leading product candidates. The company has successfully completed patient enrollment for its phase II clinical trial of
aplitabart in combination with FOLFIRI and
bevacizumab for second-line treatment of
metastatic colorectal cancer. This trial enrolled 127 patients, surpassing the initial target of 110. The study aims to evaluate the efficacy of 3 mg/kg of aplitabart in combination therapy, compared to the existing standard of FOLFIRI and bevacizumab, focusing on the primary endpoint of progression-free survival (PFS). The top-line results for PFS are anticipated by the end of the first quarter of 2025, depending on the timing of PFS events in the trial.
Additionally, IGM Biosciences announced progress in the clinical development of
imvotamab, a
CD20 x
CD3 T cell engager, for autoimmune diseases. The company has completed the first two dosing cohorts in its placebo-controlled study on severe rheumatoid arthritis and is currently enrolling patients for the third cohort. This study is structured to test three escalating dose regimens, recruiting eight patients per cohort, with six receiving imvotamab and two receiving a placebo.
Moreover, the first dose cohort in the open-label study of imvotamab in severe systemic lupus erythematosus (SLE) has been completed. This study aims to recruit six patients per dose cohort, all treated with imvotamab, and is currently enrolling for the second dose cohort, with plans to move to a third cohort subsequently.
IGM Biosciences also began enrolling patients for a single-arm, open-label study of imvotamab targeting moderate to severe idiopathic inflammatory myopathies (myositis).
Another key development is the imminent initiation of the clinical development of IGM-2644, a CD38 x CD3 T cell engager antibody intended for the treatment of autoimmune diseases. The company expects to start patient enrollment in a trial for generalized myasthenia gravis (gMG) by the end of 2024.
Financially, IGM reported cash and investments totaling $256.4 million as of June 30, 2024, a decrease from $337.7 million as of December 31, 2023. The company's collaboration revenue for Q2 2024 was $1.3 million, compared to $0.4 million in Q2 2023. Research and development expenses for the quarter were $42.0 million, down from $55.7 million the previous year, while general and administrative expenses were $10.6 million, compared to $13.0 million in the same period last year. The net loss for the second quarter of 2024 was $47.9 million, or $0.79 per share, an improvement from a net loss of $64.4 million, or $1.43 per share, in Q2 2023.
Looking ahead, IGM Biosciences anticipates full-year 2024 operating expenses between $210 million and $220 million, including approximately $40 million in non-cash stock-based compensation. The company also expects full-year collaboration revenue of around $2 million related to its agreement with Sanofi and projects to end 2024 with approximately $180 million in cash and investments, sufficient to fund its operations into the second quarter of 2026.
IGM Biosciences remains dedicated to developing novel IgM antibodies, which possess 10 binding sites compared to the 2 found in conventional IgG antibodies, offering potential advantages in treating cancer and autoimmune diseases.
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