On November 13, 2023 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported its financial results for the quarter ended September 30, 2023 (Press release, IGM Biosciences, NOV 13, 2023, View Source [SID1234637539]).

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!

"During the third quarter, we continued to execute across our clinical development pipeline," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "We have significantly expanded the number of active sites for our aplitabart randomized study, including multiple international sites, begun our Phase 1b clinical trials of imvotamab in severe systemic lupus erythematosus and severe rheumatoid arthritis and received FDA clearance of our IND application to begin a third Phase 1b autoimmune clinical trial of imvotamab. Our progress in the clinical development of these pipeline product candidates reinforces our commitment to the broad development of our Death Receptor 5 agonist platform and our T cell engager platform for autoimmune diseases."

Pipeline Progress

Aplitabart (DR5 agonist)

Clinical development of aplitabart advances.
Enrollment ongoing in the randomized colorectal cancer clinical trial. The Company continues to enroll patients in a randomized clinical trial of aplitabart, a Death Receptor 5 agonist, plus FOLFIRI and bevacizumab in second-line metastatic colorectal cancer, with a goal of enrolling approximately 110 patients by the end of the first quarter of 2024. In addition to clinical sites in the United States, this study will include multiple sites in Asia and Europe. This randomized trial is designed to assess the additional benefit of 3 mg/kg of aplitabart to the current standard of care treatment arm of FOLFIRI and bevacizumab, with a primary endpoint of progression-free survival and secondary endpoints of overall response rate and overall survival.
Dosing at 10 mg/kg ongoing in the single arm colorectal cancer clinical trial. The Company continues to treat later line colorectal cancer patients in its single arm combination clinical trial of 10 mg/kg of aplitabart and FOLFIRI. The Company expects to complete enrollment of patients in this 10 mg/kg single arm combination study in the first half of 2024.
Ongoing venetoclax combination. The Company continues to treat patients in its initial Phase 1 single arm study of aplitabart in acute myeloid leukemia in combination with venetoclax and azacytidine.
Ongoing birinapant combination. The Company continues to treat patients in its aplitabart plus birinapant Phase 1 combination cohort.
Imvotamab (CD20 x CD3)

Two autoimmune clinical trials ongoing. Following the clearance of the Company’s two Investigational New Drug (IND) applications with the U.S. Food and Drug Administration (FDA) for imvotamab, an IgM-based CD20 x CD3 bispecific antibody T cell engager, the Company has begun two Phase 1b clinical trials, one in severe systemic lupus erythematosus (SLE) and one in severe rheumatoid arthritis (RA).
FDA clearance to begin third autoimmune clinical trial. In the third quarter, the Company received clearance from the FDA of its IND application for the use of imvotamab in treating idiopathic inflammatory myopathies (myositis).
Imvotamab preclinical data. In November 2023, the Company presented preclinical data for imvotamab at the American College of Rheumatology Annual Meeting. The results were featured in a poster presentation titled "Therapeutic Potential of Imvotamab, a CD20-Targeted Bispecific IgM T Cell Engager, for the Treatment of Refractory Autoimmune Disease Patients", which highlighted the ability of imvotamab to effectively deplete CD20+ B cells in tissue as well as to deplete low expressing CD20+ cells. These preclinical results support the advancement of imvotamab into Phase 1b clinical trials in autoimmune disease and may indicate differentiated activity as compared to anti-CD20 IgG1 antibodies.
IGM-7354 (IL-15 x PD-L1)

Phase 1 trial continues. The Company continues to treat patients in a Phase 1 clinical trial exploring the safety, efficacy, and biomarker activity of IGM-7354, an IgM-targeted immunostimulatory IL-15 cytokine, in the treatment of patients with solid tumors.
IGM-2644 (CD38 x CD3)

Phase 1 trial continues. The Company continues to treat patients in a Phase 1 clinical trial exploring the safety and efficacy of IGM-2644, a CD38 x CD3 IgM T cell engaging antibody, in patients with recurrent or refractory multiple myeloma.
Third Quarter 2023 Financial Results

Cash and Investments: Cash and investments as of September 30, 2023 were $387.0 million, compared to $427.2 million as of December 31, 2022.
Collaboration Revenue: For the third quarter of 2023, collaboration revenues were $0.5 million, compared to $0.3 million for the same period in 2022.
Research and Development (R&D) Expenses: For the third quarter of 2023, R&D expenses were $54.8 million, compared to $48.2 million for the same period in 2022.
General and Administrative (G&A) Expenses: For the third quarter of 2023, G&A expenses were $12.5 million, compared to $12.7 million for the same period in 2022.
Net Loss: For the third quarter of 2023, net loss was $62.0 million, or a loss of $1.04 per share, compared to a net loss of $58.0 million, or a loss of $1.32 per share, for the same period in 2022.
2023 Financial Guidance

The Company expects full year 2023 GAAP operating expenses of $275 million to $285 million, including estimated non-cash stock-based compensation expense of approximately $50 million, and full year collaboration revenue of approximately $2 million related to the Sanofi agreement. The Company expects to end 2023 with more than $325 million in cash and investments, and the Company expects its existing cash and investments and anticipated collaboration payments to fund operations into the second half of 2025.