On August 14, 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 June 30, 2024 and provided an update on recent developments (Press release, IGM Biosciences, AUG 14, 2024, View Source [SID1234645903]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We continue to make significant progress in the clinical development of our two lead product candidates," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "We are pleased to have completed enrollment of 127 patients in our randomized study of 3mg/kg of aplitabart plus FOLFIRI and bevacizumab in second line colorectal cancer. We are also pleased to have successfully cleared the first two cohorts of our clinical trial of imvotamab in severe rheumatoid arthritis as well as the first cohort of our clinical trial of imvotamab in severe systemic lupus erythematosus."

Pipeline Updates

Aplitabart (death receptor 5 agonist)

Clinical development of aplitabart advances.
Enrollment completed in randomized colorectal cancer clinical trial. The Company announced that it has completed enrollment in its randomized clinical trial of 3 mg/kg of aplitabart plus FOLFIRI and bevacizumab in second-line metastatic colorectal cancer. A total of 127 patients, exceeding the trial design target of 110 patients, were enrolled across multiple clinical trial sites in the United States, Asia and Europe. This randomized trial is designed to assess the benefit of 3 mg/kg of aplitabart when administered in combination with FOLFIRI and bevacizumab compared to the current standard of care treatment of FOLFIRI and bevacizumab, with a primary endpoint of progression-free survival (PFS). The release of data from this randomized clinical trial will depend on the timing of PFS events in both the control and the experimental arms of this study. Based on its assumptions as to the timing of PFS events, the Company expects to be able to release top-line PFS results from this study by the end of the first quarter of 2025.
Imvotamab (CD20 x CD3 T cell engager)

Clinical development of imvotamab in autoimmune diseases advances.
First and second dose cohorts in rheumatoid arthritis successfully completed. The Company announced that it has cleared both the first and second dose cohorts of its placebo-controlled clinical study testing imvotamab in severe rheumatoid arthritis and is currently enrolling the third cohort. This study is designed to evaluate three cohorts of progressively higher dose regimens of imvotamab, with each cohort designed to recruit eight patients, six of whom receive imvotamab and two of whom receive placebo.
First dose cohort in systemic lupus erythematosus successfully completed. The Company announced that it has cleared the first dose cohort of its open-label clinical study testing imvotamab in severe systemic lupus erythematosus (SLE), with each dose cohort designed to recruit six patients, all of whom are to be treated with imvotamab. The Company is currently enrolling patients in a second dose cohort and plans to enroll a third dose cohort, with each cohort at progressively higher dose regimens of imvotamab.
Enrollment initiated in myositis. The Company has initiated recruitment of patients in its single arm, open-label clinical study testing imvotamab in moderate-severe idiopathic inflammatory myopathies (myositis).
IGM-2644 (CD38 x CD3 T cell engager)

Clinical development of IGM-2644 in autoimmune diseases to be initiated. The Company has made 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 currently expects to begin enrolling patients in a single arm, open-label clinical study testing IGM-2644 in generalized myasthenia gravis (gMG) by the end of 2024.
Second Quarter 2024 Financial Results

Cash and Investments: Cash and investments as of June 30, 2024 were $256.4 million, compared to $337.7 million as of December 31, 2023.
Collaboration Revenue: For the second quarter of 2024, collaboration revenues were $1.3 million compared to $0.4 million for the second quarter of 2023.
Research and Development (R&D) Expenses: For the second quarter of 2024, R&D expenses were $42.0 million, compared to $55.7 million for the second quarter of 2023.
General and Administrative (G&A) Expenses: For the second quarter of 2024, G&A expenses were $10.6 million, compared to $13.0 million for the second quarter of 2023.
Net Loss: For the second quarter of 2024, net loss was $47.9 million, or a loss of $0.79 per share, compared to a net loss of $64.4 million, or a loss of $1.43 per share, for the second quarter of 2023.
2024 Financial Guidance
The Company expects full year 2024 GAAP operating expenses of $210 million to $220 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 the second quarter of 2026.