IGM Biosciences Reports Q1 2024 Financial Results and Corporate Update

IGM Biosciences, Inc., a clinical-stage biotechnology firm specializing in engineered IgM antibodies, has released its financial results for the quarter ending March 31, 2024, and shared updates on recent clinical developments.

Fred Schwarzer, CEO of IGM Biosciences, expressed satisfaction with the company's progress in its clinical trials for aplitabart and imvotamab. The company has surpassed its enrollment target of 110 patients in its randomized study of aplitabart at a dosage of 3 mg/kg, used alongside FOLFIRI and bevacizumab for second-line colorectal cancer. With additional patients still receiving their initial doses, the final enrollment is expected to exceed 120 patients. Additionally, the company has completed enrollment in the first dose cohort of its imvotamab trial for severe rheumatoid arthritis.

Clinical Developments

Aplitabart (DR5 Agonist)
The clinical development of aplitabart has seen significant progress. IGM Biosciences has exceeded its enrollment goal for a randomized clinical trial involving 3 mg/kg of aplitabart combined with FOLFIRI and bevacizumab for treating second-line metastatic colorectal cancer. Patients were recruited from various sites in the U.S., Asia, and Europe. This study aims to evaluate the benefits of aplitabart in combination with existing treatments, using progression-free survival (PFS) as the primary endpoint. Based on the expected timing of PFS events, the top-line results are anticipated by the end of Q1 2025.

Additionally, the company has met its enrollment target of 20 patients for a single-arm clinical trial examining a 10 mg/kg dose of aplitabart combined with FOLFIRI and bevacizumab for later-line colorectal cancer patients.

Imvotamab (CD20 x CD3)
IGM Biosciences has completed the first dose cohort enrollment for its imvotamab clinical trial in severe rheumatoid arthritis. In this cohort, six patients received imvotamab, and two were given a placebo. Two subsequent dose cohorts are planned, each involving six patients on imvotamab and two on placebo, with increasing dosage levels in each cohort. This trial is expanding to include international sites alongside U.S. locations.

Enrollment is ongoing for the first dose cohort of imvotamab in severe systemic lupus erythematosus (SLE). This cohort will include six patients, all receiving imvotamab. Two additional dose cohorts are planned, with dosage levels increasing in each subsequent cohort.

The company is also initiating a clinical trial for imvotamab in idiopathic inflammatory myopathies (myositis) and expects to start enrolling patients in the current quarter.

IGM-2644 (CD38 x CD3)
Plans are underway to commence clinical development of IGM-2644, a CD38 x CD3 T cell engager antibody, for treating autoimmune diseases.

Financial Performance

For Q1 2024, IGM Biosciences reported cash and investments of $293.8 million, down from $337.7 million at the end of 2023. Collaboration revenues were consistent at $0.5 million for both Q1 2024 and Q1 2023. Research and development expenses decreased to $43.8 million from $50.9 million year-over-year, while general and administrative expenses also saw a reduction, falling to $10.5 million from $13.0 million. The net loss for Q1 2024 was $49.8 million, or $0.83 per share, compared to $59.3 million, or $1.33 per share, for Q1 2023.

2024 Financial Outlook

The company projects full-year 2024 GAAP operating expenses to range between $210 million and $220 million, including approximately $40 million in non-cash stock-based compensation. Due to a refocusing of its collaboration with Sanofi, IGM expects to recognize $63 million in collaboration revenue for the year, with $62 million expected in Q2. The company anticipates ending 2024 with around $180 million in cash and investments, sufficient to fund operations into the second quarter of 2026.

IGM Biosciences remains dedicated to advancing its innovative IgM antibodies and expanding its pipeline to address cancer and autoimmune diseases effectively.

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